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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00856856




Registration number
NCT00856856
Ethics application status
Date submitted
27/02/2009
Date registered
4/03/2009
Date last updated
4/09/2018

Titles & IDs
Public title
ABSORB Clinical Investigation, Cohort B
Scientific title
A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.
Secondary ID [1] 0 0
05-370 Cohort B
Universal Trial Number (UTN)
Trial acronym
ABSORB B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Disease 0 0
Coronary Artery Disease 0 0
Coronary Restenosis 0 0
Coronary Disease 0 0
Coronary Artery Disease 0 0
Coronary Restenosis 0 0
Coronary Disease 0 0
Coronary Artery Disease 0 0
Coronary Restenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Bioabsorbable Everolimus Eluting Coronary Stent
Treatment: Devices - Bioabsorbable Everolimus Eluting Coronary Stent
Treatment: Devices - Bioabsorbable Everolimus Eluting Coronary Stent

Experimental: Absorb stent - Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)

Experimental: Absorb stent - Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)

Experimental: Absorb stent - Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)


Treatment: Devices: Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease

Treatment: Devices: Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease

Treatment: Devices: Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [2] 0 0
1 year
Primary outcome [3] 0 0
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Timepoint [3] 0 0
180 days
Primary outcome [4] 0 0
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up
Timepoint [4] 0 0
1 year
Primary outcome [5] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [5] 0 0
30 days
Primary outcome [6] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [6] 0 0
1 year
Primary outcome [7] 0 0
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Timepoint [7] 0 0
180 days
Primary outcome [8] 0 0
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up
Timepoint [8] 0 0
1 year
Primary outcome [9] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [9] 0 0
30 days
Primary outcome [10] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [10] 0 0
1 year
Primary outcome [11] 0 0
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Timepoint [11] 0 0
180 days
Primary outcome [12] 0 0
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up
Timepoint [12] 0 0
1 year
Secondary outcome [1] 0 0
Clinical Device Success (Per Lesion) - Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.
Timepoint [1] 0 0
On day 0 (the day of procedure)
Secondary outcome [2] 0 0
Clinical Procedure Success (Per Patient) - Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.
Timepoint [2] 0 0
On day 0 (the day of procedure)
Secondary outcome [3] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [3] 0 0
180 days
Secondary outcome [4] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [4] 0 0
270 days
Secondary outcome [5] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [7] 0 0
4 years
Secondary outcome [8] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [8] 0 0
5 years
Secondary outcome [9] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [9] 0 0
30 days
Secondary outcome [10] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [10] 0 0
180 days
Secondary outcome [11] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [11] 0 0
270 days
Secondary outcome [12] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [12] 0 0
1 year
Secondary outcome [13] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [13] 0 0
2 years
Secondary outcome [14] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [14] 0 0
3 years
Secondary outcome [15] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [15] 0 0
4 years
Secondary outcome [16] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [16] 0 0
5 years
Secondary outcome [17] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [17] 0 0
30 days
Secondary outcome [18] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [18] 0 0
180 days
Secondary outcome [19] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [19] 0 0
270 days
Secondary outcome [20] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [20] 0 0
1 year
Secondary outcome [21] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [21] 0 0
2 years
Secondary outcome [22] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [22] 0 0
3 years
Secondary outcome [23] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [23] 0 0
4 years
Secondary outcome [24] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [24] 0 0
5 years
Secondary outcome [25] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [25] 0 0
30 days
Secondary outcome [26] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [26] 0 0
180 days
Secondary outcome [27] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [27] 0 0
270 days
Secondary outcome [28] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [28] 0 0
1 year
Secondary outcome [29] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [29] 0 0
2 years
Secondary outcome [30] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [30] 0 0
3 years
Secondary outcome [31] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [31] 0 0
4 years
Secondary outcome [32] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [32] 0 0
5 years
Secondary outcome [33] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [33] 0 0
30 days
Secondary outcome [34] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [34] 0 0
1 year
Secondary outcome [35] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [35] 0 0
2 years
Secondary outcome [36] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [36] 0 0
3 years
Secondary outcome [37] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [37] 0 0
4 years
Secondary outcome [38] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [38] 0 0
5 years
Secondary outcome [39] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of Creatine kinase (CK) levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [39] 0 0
30 days
Secondary outcome [40] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [40] 0 0
1 year
Secondary outcome [41] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [41] 0 0
2 years
Secondary outcome [42] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [42] 0 0
3 years
Secondary outcome [43] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [43] 0 0
4 years
Secondary outcome [44] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [44] 0 0
5 years
Secondary outcome [45] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [45] 0 0
30 days
Secondary outcome [46] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [46] 0 0
1 year
Secondary outcome [47] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [47] 0 0
2 years
Secondary outcome [48] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [48] 0 0
3 years
Secondary outcome [49] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [49] 0 0
4 years
Secondary outcome [50] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [50] 0 0
5 years
Secondary outcome [51] 0 0
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Timepoint [51] 0 0
2 years
Secondary outcome [52] 0 0
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Timepoint [52] 0 0
3 years
Secondary outcome [53] 0 0
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Timepoint [53] 0 0
5 years
Secondary outcome [54] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [54] 0 0
180 days
Secondary outcome [55] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [55] 0 0
1 year
Secondary outcome [56] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [56] 0 0
2 years
Secondary outcome [57] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [57] 0 0
3 years
Secondary outcome [58] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [58] 0 0
5 years
Secondary outcome [59] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [59] 0 0
180 days
Secondary outcome [60] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [60] 0 0
1 year
Secondary outcome [61] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [61] 0 0
2 years
Secondary outcome [62] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [62] 0 0
3 years
Secondary outcome [63] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [63] 0 0
5 years
Secondary outcome [64] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [64] 0 0
180 days
Secondary outcome [65] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [65] 0 0
1 year
Secondary outcome [66] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [66] 0 0
2 years
Secondary outcome [67] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [67] 0 0
3 years
Secondary outcome [68] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [68] 0 0
5 years
Secondary outcome [69] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [69] 0 0
180 days
Secondary outcome [70] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [70] 0 0
1 year
Secondary outcome [71] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [71] 0 0
2 years
Secondary outcome [72] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [72] 0 0
3 years
Secondary outcome [73] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [73] 0 0
5 years
Secondary outcome [74] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [74] 0 0
180 days
Secondary outcome [75] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [75] 0 0
1 year
Secondary outcome [76] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [76] 0 0
2 years
Secondary outcome [77] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [77] 0 0
3 years
Secondary outcome [78] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [78] 0 0
5 years
Secondary outcome [79] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [79] 0 0
180 days
Secondary outcome [80] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [80] 0 0
1 year
Secondary outcome [81] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [81] 0 0
2 years
Secondary outcome [82] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [82] 0 0
3 years
Secondary outcome [83] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [83] 0 0
5 years
Secondary outcome [84] 0 0
Thrombus
Timepoint [84] 0 0
180 days
Secondary outcome [85] 0 0
Thrombus
Timepoint [85] 0 0
1 year
Secondary outcome [86] 0 0
Thrombus
Timepoint [86] 0 0
2 years
Secondary outcome [87] 0 0
Thrombus
Timepoint [87] 0 0
3 years
Secondary outcome [88] 0 0
Thrombus
Timepoint [88] 0 0
5 years
Secondary outcome [89] 0 0
Vasomotion Analysis: In-scaffold Mean Luminal Diameter - Vasomotion function was assessed in reaction to nitrate administration.
Timepoint [89] 0 0
5 years
Secondary outcome [90] 0 0
Volume Obstruction (VO) - Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Timepoint [90] 0 0
180 days
Secondary outcome [91] 0 0
Volume Obstruction (VO) - Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Timepoint [91] 0 0
1 year
Secondary outcome [92] 0 0
Volume Obstruction (VO) - Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Timepoint [92] 0 0
2 year
Secondary outcome [93] 0 0
Volume Obstruction (VO) - Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Timepoint [93] 0 0
3 year
Secondary outcome [94] 0 0
Persisting Incomplete Apposition - Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [94] 0 0
180 days
Secondary outcome [95] 0 0
Persisting Incomplete Apposition - Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [95] 0 0
1 year
Secondary outcome [96] 0 0
Persisting Incomplete Apposition - Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [96] 0 0
2 year
Secondary outcome [97] 0 0
Persisting Incomplete Apposition - Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [97] 0 0
3 year
Secondary outcome [98] 0 0
Late Incomplete Apposition - Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [98] 0 0
180 days
Secondary outcome [99] 0 0
Late Incomplete Apposition - Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [99] 0 0
1 year
Secondary outcome [100] 0 0
Late Incomplete Apposition - Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [100] 0 0
2 year
Secondary outcome [101] 0 0
Late Incomplete Apposition - Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [101] 0 0
3 year
Secondary outcome [102] 0 0
Clinical Device Success (Per Lesion) - Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.
Timepoint [102] 0 0
On day 0 (the day of procedure)
Secondary outcome [103] 0 0
Clinical Procedure Success (Per Patient) - Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.
Timepoint [103] 0 0
On day 0 (the day of procedure)
Secondary outcome [104] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [104] 0 0
180 days
Secondary outcome [105] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [105] 0 0
270 days
Secondary outcome [106] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [106] 0 0
2 years
Secondary outcome [107] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [107] 0 0
3 years
Secondary outcome [108] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [108] 0 0
4 years
Secondary outcome [109] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [109] 0 0
5 years
Secondary outcome [110] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [110] 0 0
30 days
Secondary outcome [111] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [111] 0 0
180 days
Secondary outcome [112] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [112] 0 0
270 days
Secondary outcome [113] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [113] 0 0
1 year
Secondary outcome [114] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [114] 0 0
2 years
Secondary outcome [115] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [115] 0 0
3 years
Secondary outcome [116] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [116] 0 0
4 years
Secondary outcome [117] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [117] 0 0
5 years
Secondary outcome [118] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [118] 0 0
30 days
Secondary outcome [119] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [119] 0 0
180 days
Secondary outcome [120] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [120] 0 0
270 days
Secondary outcome [121] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [121] 0 0
1 year
Secondary outcome [122] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [122] 0 0
2 years
Secondary outcome [123] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [123] 0 0
3 years
Secondary outcome [124] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [124] 0 0
4 years
Secondary outcome [125] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [125] 0 0
5 years
Secondary outcome [126] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [126] 0 0
30 days
Secondary outcome [127] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [127] 0 0
180 days
Secondary outcome [128] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [128] 0 0
270 days
Secondary outcome [129] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [129] 0 0
1 year
Secondary outcome [130] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [130] 0 0
2 years
Secondary outcome [131] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [131] 0 0
3 years
Secondary outcome [132] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [132] 0 0
4 years
Secondary outcome [133] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [133] 0 0
5 years
Secondary outcome [134] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [134] 0 0
30 days
Secondary outcome [135] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [135] 0 0
1 year
Secondary outcome [136] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [136] 0 0
2 years
Secondary outcome [137] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [137] 0 0
3 years
Secondary outcome [138] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [138] 0 0
4 years
Secondary outcome [139] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [139] 0 0
5 years
Secondary outcome [140] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of Creatine kinase (CK) levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [140] 0 0
30 days
Secondary outcome [141] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [141] 0 0
1 year
Secondary outcome [142] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [142] 0 0
2 years
Secondary outcome [143] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [143] 0 0
3 years
Secondary outcome [144] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [144] 0 0
4 years
Secondary outcome [145] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [145] 0 0
5 years
Secondary outcome [146] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [146] 0 0
30 days
Secondary outcome [147] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [147] 0 0
1 year
Secondary outcome [148] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [148] 0 0
2 years
Secondary outcome [149] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [149] 0 0
3 years
Secondary outcome [150] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [150] 0 0
4 years
Secondary outcome [151] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [151] 0 0
5 years
Secondary outcome [152] 0 0
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Timepoint [152] 0 0
2 years
Secondary outcome [153] 0 0
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Timepoint [153] 0 0
3 years
Secondary outcome [154] 0 0
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Timepoint [154] 0 0
5 years
Secondary outcome [155] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [155] 0 0
180 days
Secondary outcome [156] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [156] 0 0
1 year
Secondary outcome [157] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [157] 0 0
2 years
Secondary outcome [158] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [158] 0 0
3 years
Secondary outcome [159] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [159] 0 0
5 years
Secondary outcome [160] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [160] 0 0
180 days
Secondary outcome [161] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [161] 0 0
1 year
Secondary outcome [162] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [162] 0 0
2 years
Secondary outcome [163] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [163] 0 0
3 years
Secondary outcome [164] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [164] 0 0
5 years
Secondary outcome [165] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [165] 0 0
180 days
Secondary outcome [166] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [166] 0 0
1 year
Secondary outcome [167] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [167] 0 0
2 years
Secondary outcome [168] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [168] 0 0
3 years
Secondary outcome [169] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [169] 0 0
5 years
Secondary outcome [170] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [170] 0 0
180 days
Secondary outcome [171] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [171] 0 0
1 year
Secondary outcome [172] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [172] 0 0
2 years
Secondary outcome [173] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [173] 0 0
3 years
Secondary outcome [174] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [174] 0 0
5 years
Secondary outcome [175] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [175] 0 0
180 days
Secondary outcome [176] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [176] 0 0
1 year
Secondary outcome [177] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [177] 0 0
2 years
Secondary outcome [178] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [178] 0 0
3 years
Secondary outcome [179] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [179] 0 0
5 years
Secondary outcome [180] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [180] 0 0
180 days
Secondary outcome [181] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [181] 0 0
1 year
Secondary outcome [182] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [182] 0 0
2 years
Secondary outcome [183] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [183] 0 0
3 years
Secondary outcome [184] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [184] 0 0
5 years
Secondary outcome [185] 0 0
Thrombus
Timepoint [185] 0 0
180 days
Secondary outcome [186] 0 0
Thrombus
Timepoint [186] 0 0
1 year
Secondary outcome [187] 0 0
Thrombus
Timepoint [187] 0 0
2 years
Secondary outcome [188] 0 0
Thrombus
Timepoint [188] 0 0
3 years
Secondary outcome [189] 0 0
Thrombus
Timepoint [189] 0 0
5 years
Secondary outcome [190] 0 0
Vasomotion Analysis: In-scaffold Mean Luminal Diameter - Vasomotion function was assessed in reaction to nitrate administration.
Timepoint [190] 0 0
5 years
Secondary outcome [191] 0 0
Volume Obstruction (VO) - Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Timepoint [191] 0 0
180 days
Secondary outcome [192] 0 0
Volume Obstruction (VO) - Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Timepoint [192] 0 0
1 year
Secondary outcome [193] 0 0
Volume Obstruction (VO) - Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Timepoint [193] 0 0
2 year
Secondary outcome [194] 0 0
Volume Obstruction (VO) - Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Timepoint [194] 0 0
3 year
Secondary outcome [195] 0 0
Persisting Incomplete Apposition - Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [195] 0 0
180 days
Secondary outcome [196] 0 0
Persisting Incomplete Apposition - Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [196] 0 0
1 year
Secondary outcome [197] 0 0
Persisting Incomplete Apposition - Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [197] 0 0
2 year
Secondary outcome [198] 0 0
Persisting Incomplete Apposition - Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [198] 0 0
3 year
Secondary outcome [199] 0 0
Late Incomplete Apposition - Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [199] 0 0
180 days
Secondary outcome [200] 0 0
Late Incomplete Apposition - Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [200] 0 0
1 year
Secondary outcome [201] 0 0
Late Incomplete Apposition - Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [201] 0 0
2 year
Secondary outcome [202] 0 0
Late Incomplete Apposition - Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [202] 0 0
3 year
Secondary outcome [203] 0 0
Clinical Device Success (Per Lesion) - Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.
Timepoint [203] 0 0
On day 0 (the day of procedure)
Secondary outcome [204] 0 0
Clinical Procedure Success (Per Patient) - Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.
Timepoint [204] 0 0
On day 0 (the day of procedure)
Secondary outcome [205] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [205] 0 0
180 days
Secondary outcome [206] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [206] 0 0
270 days
Secondary outcome [207] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [207] 0 0
2 years
Secondary outcome [208] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [208] 0 0
3 years
Secondary outcome [209] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [209] 0 0
4 years
Secondary outcome [210] 0 0
Hierarchical Major Adverse Cardiac Event (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Timepoint [210] 0 0
5 years
Secondary outcome [211] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [211] 0 0
30 days
Secondary outcome [212] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [212] 0 0
180 days
Secondary outcome [213] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [213] 0 0
270 days
Secondary outcome [214] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [214] 0 0
1 year
Secondary outcome [215] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [215] 0 0
2 years
Secondary outcome [216] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [216] 0 0
3 years
Secondary outcome [217] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [217] 0 0
4 years
Secondary outcome [218] 0 0
Hierarchical Target Vessel Failure (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [218] 0 0
5 years
Secondary outcome [219] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [219] 0 0
30 days
Secondary outcome [220] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [220] 0 0
180 days
Secondary outcome [221] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [221] 0 0
270 days
Secondary outcome [222] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [222] 0 0
1 year
Secondary outcome [223] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [223] 0 0
2 years
Secondary outcome [224] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [224] 0 0
3 years
Secondary outcome [225] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [225] 0 0
4 years
Secondary outcome [226] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR) - ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [226] 0 0
5 years
Secondary outcome [227] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [227] 0 0
30 days
Secondary outcome [228] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [228] 0 0
180 days
Secondary outcome [229] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [229] 0 0
270 days
Secondary outcome [230] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [230] 0 0
1 year
Secondary outcome [231] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [231] 0 0
2 years
Secondary outcome [232] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [232] 0 0
3 years
Secondary outcome [233] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [233] 0 0
4 years
Secondary outcome [234] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR) - ID-TVR is the revascularization in the target vessel associated with any of the following:
Positive functional ischemia study
Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA)
Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Timepoint [234] 0 0
5 years
Secondary outcome [235] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [235] 0 0
30 days
Secondary outcome [236] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [236] 0 0
1 year
Secondary outcome [237] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [237] 0 0
2 years
Secondary outcome [238] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [238] 0 0
3 years
Secondary outcome [239] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [239] 0 0
4 years
Secondary outcome [240] 0 0
Cardiac Death - Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Timepoint [240] 0 0
5 years
Secondary outcome [241] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of Creatine kinase (CK) levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [241] 0 0
30 days
Secondary outcome [242] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [242] 0 0
1 year
Secondary outcome [243] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [243] 0 0
2 years
Secondary outcome [244] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [244] 0 0
3 years
Secondary outcome [245] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [245] 0 0
4 years
Secondary outcome [246] 0 0
Myocardial Infarction - Myocardial Infarction (MI):
Q wave MI: Development of new, pathological Q wave on the ECG.
Non-Q wave MI: Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Timepoint [246] 0 0
5 years
Secondary outcome [247] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [247] 0 0
30 days
Secondary outcome [248] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [248] 0 0
1 year
Secondary outcome [249] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [249] 0 0
2 years
Secondary outcome [250] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [250] 0 0
3 years
Secondary outcome [251] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [251] 0 0
4 years
Secondary outcome [252] 0 0
Scaffold Thrombosis - Scaffold thrombosis will be categorized as acute (= 1day), subacute (>1day = 30 days) and late (>30 days) and will be defined as any of the following:
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Timepoint [252] 0 0
5 years
Secondary outcome [253] 0 0
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Timepoint [253] 0 0
2 years
Secondary outcome [254] 0 0
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Timepoint [254] 0 0
3 years
Secondary outcome [255] 0 0
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years - In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Timepoint [255] 0 0
5 years
Secondary outcome [256] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [256] 0 0
180 days
Secondary outcome [257] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [257] 0 0
1 year
Secondary outcome [258] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [258] 0 0
2 years
Secondary outcome [259] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [259] 0 0
3 years
Secondary outcome [260] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years - Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Timepoint [260] 0 0
5 years
Secondary outcome [261] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [261] 0 0
180 days
Secondary outcome [262] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [262] 0 0
1 year
Secondary outcome [263] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [263] 0 0
2 years
Secondary outcome [264] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [264] 0 0
3 years
Secondary outcome [265] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years - Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Timepoint [265] 0 0
5 years
Secondary outcome [266] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [266] 0 0
180 days
Secondary outcome [267] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [267] 0 0
1 year
Secondary outcome [268] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [268] 0 0
2 years
Secondary outcome [269] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [269] 0 0
3 years
Secondary outcome [270] 0 0
In-scaffold Angiographic Binary Restenosis (ABR) - Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Timepoint [270] 0 0
5 years
Secondary outcome [271] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [271] 0 0
180 days
Secondary outcome [272] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [272] 0 0
1 year
Secondary outcome [273] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [273] 0 0
2 years
Secondary outcome [274] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [274] 0 0
3 years
Secondary outcome [275] 0 0
Persisting Dissection - Dissection at follow-up that was present post-procedure.
Timepoint [275] 0 0
5 years
Secondary outcome [276] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [276] 0 0
180 days
Secondary outcome [277] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [277] 0 0
1 year
Secondary outcome [278] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [278] 0 0
2 years
Secondary outcome [279] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [279] 0 0
3 years
Secondary outcome [280] 0 0
In-scaffold Percent Diameter Stenosis (%DS) - Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Timepoint [280] 0 0
5 years
Secondary outcome [281] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [281] 0 0
180 days
Secondary outcome [282] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [282] 0 0
1 year
Secondary outcome [283] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [283] 0 0
2 years
Secondary outcome [284] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [284] 0 0
3 years
Secondary outcome [285] 0 0
Aneurysm - An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Timepoint [285] 0 0
5 years
Secondary outcome [286] 0 0
Thrombus
Timepoint [286] 0 0
180 days
Secondary outcome [287] 0 0
Thrombus
Timepoint [287] 0 0
1 year
Secondary outcome [288] 0 0
Thrombus
Timepoint [288] 0 0
2 years
Secondary outcome [289] 0 0
Thrombus
Timepoint [289] 0 0
3 years
Secondary outcome [290] 0 0
Thrombus
Timepoint [290] 0 0
5 years
Secondary outcome [291] 0 0
Vasomotion Analysis: In-scaffold Mean Luminal Diameter - Vasomotion function was assessed in reaction to nitrate administration.
Timepoint [291] 0 0
5 years
Secondary outcome [292] 0 0
Volume Obstruction (VO) - Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Timepoint [292] 0 0
180 days
Secondary outcome [293] 0 0
Volume Obstruction (VO) - Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Timepoint [293] 0 0
1 year
Secondary outcome [294] 0 0
Volume Obstruction (VO) - Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Timepoint [294] 0 0
2 year
Secondary outcome [295] 0 0
Volume Obstruction (VO) - Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Timepoint [295] 0 0
3 year
Secondary outcome [296] 0 0
Persisting Incomplete Apposition - Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [296] 0 0
180 days
Secondary outcome [297] 0 0
Persisting Incomplete Apposition - Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [297] 0 0
1 year
Secondary outcome [298] 0 0
Persisting Incomplete Apposition - Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [298] 0 0
2 year
Secondary outcome [299] 0 0
Persisting Incomplete Apposition - Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [299] 0 0
3 year
Secondary outcome [300] 0 0
Late Incomplete Apposition - Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [300] 0 0
180 days
Secondary outcome [301] 0 0
Late Incomplete Apposition - Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [301] 0 0
1 year
Secondary outcome [302] 0 0
Late Incomplete Apposition - Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [302] 0 0
2 year
Secondary outcome [303] 0 0
Late Incomplete Apposition - Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Timepoint [303] 0 0
3 year

Eligibility
Key inclusion criteria
General inclusion criteria

1. Patient must be at least 18 years of age.

2. Patient is able to verbally confirm understanding of risks, benefits and treatment
alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally
authorized representative provides written informed consent prior to any Clinical
Investigation related procedure, as approved by the appropriate Ethics Committee of
the respective clinical site.

3. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina,
silent ischemia, positive functional study or a reversible change in the
electrocardiogram (ECG) consistent with ischemia)

4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG)
surgery

5. Patient must agree to undergo all clinical investigation plan-required follow-up
visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical
coherence tomography (OCT) (strongly recommended), multislice computed tomography
(MSCT) (optional) and coronary vasomotion (optional)

6. Patient must agree not to participate in any other clinical investigation for a period
of two years following the index procedure

Angiographic Inclusion Criteria

1. Target lesion(s) must be located in a native coronary artery with visually estimated
nominal vessel diameter of 3.0 mm

2. Target lesion(s) must measure = 14 mm in length by visual estimation

3. Target lesion(s) must be in a major artery or branch with a visually estimated
stenosis of = 50% and < 100% with a TIMI flow of = 1

4. If two target lesions meet the inclusion criteria they must be in different major
epicardial vessels left anterior descending artery (LAD) with septal and diagonal
branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius
branches and right coronary artery (RCA) and any of its branches

5. If two target lesion(s) are being treated, each of these lesions must meet all
angiographic inclusion/exclusion criteria

6. Non-Clinical Investigation, percutaneous intervention for lesions in a non-target
vessel is allowed if done = 90 days prior to or if planned to be done 6 months after
the index procedure

7. Non-Clinical Investigation percutaneous intervention for lesion in the target vessel
is allowed if done > 6 months prior to or if planned to be done 6 months after the
index procedure

General
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days
preceding the index procedure and creatine kinase (CK) and CK-MB have not returned
within normal limits at the time of procedure

2. The patient is currently experiencing clinical symptoms consistent with AMI

3. Patient has current unstable arrhythmias

4. Patient has a known left ventricular ejection fraction (LVEF) < 30%

5. Patient has received a heart transplant or any other organ transplant or is on a
waiting list for any organ transplant

6. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30
days prior to or after the procedure

7. Patient is receiving immunosuppression therapy and has known immunosuppressive or
autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus
etc.)

8. Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g.,
heparin, coumadin)

9. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and
bivalirudin, both clopidogrel and ticlopidine, everolimus, poly (L-lactide), poly
(DL-lactide) or contrast sensitivity that cannot be adequately pre-medicated

10. Elective surgery is planned within the first 6 months after the procedure that will
require discontinuing either aspirin or clopidogrel

11. Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood
cell count of < 3,000 cells/mm3, or documented or suspected liver disease (including
laboratory evidence of hepatitis)

12. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5
mg/dL, or patient on dialysis)

13. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood
transfusions

14. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological
attack (TIA) within the past six months

15. Patient has had a significant GI or urinary bleed within the past six months

16. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath
insertion

17. Patient has other medical illness (e.g., cancer or congestive heart failure) or known
history of substance abuse (alcohol, cocaine, heroin etc.) that may cause
non-compliance with the clinical investigation plan, confound the data interpretation
or is associated with a limited life expectancy (i.e., less than one year)

18. Patient is already participating in another clinical investigation that has not yet
reached its primary endpoint

19. Pregnant or nursing patients and those who plan pregnancy during the Clinical
Investigation. (Female patients of child-bearing potential must have a negative
pregnancy test done within 7 days prior to the index procedure and effective
contraception must be used during participation in this Clinical Investigation)

20. Patient has received brachytherapy in any epicardial vessel (including side branches)

Angiographic Exclusion Criteria

1. Target lesion(s) meets any of the following criteria:

1. Aorto-ostial location (within 3 mm)

2. Left main location

3. Located within 2 mm of the origin of the LAD or LCX

4. Located within an arterial or saphenous vein graft or distal to a diseased
(defined as vessel irregularity per angiogram and > 20% stenosed lesion, by
visual estimation) arterial or saphenous vein graft

5. Lesion involving a bifurcation = 2 mm in diameter and ostial lesion > 40%
stenosed by visual estimation or side branch requiring predilatation

6. Total occlusion (TIMI flow 0), prior to wire crossing

7. Excessive tortuosity proximal to or within the lesion

8. Extreme angulation (= 90%) proximal to or within the lesion

9. Heavy calcification

10. Restenotic from previous intervention

2. The target vessel contains visible thrombus

3. Another clinically significant lesion is located in the same major epicardial vessel
as the target lesion(s) (including side branches)

4. Patient has a high probability that a procedure other than pre-dilatation and stenting
and (if necessary) post-dilatation will be required at the time of index procedure for
treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [2] 0 0
Monash Heart - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Denmark
State/province [2] 0 0
Aarhus
Country [3] 0 0
France
State/province [3] 0 0
Massy
Country [4] 0 0
Netherlands
State/province [4] 0 0
Eindhoven
Country [5] 0 0
Netherlands
State/province [5] 0 0
Rotterdam
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
New Zealand
State/province [7] 0 0
Christchurch
Country [8] 0 0
Poland
State/province [8] 0 0
Krakow
Country [9] 0 0
Switzerland
State/province [9] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and performance of the BVS Everolimus
Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de
novo native coronary artery lesions located in two different major epicardial vessels.

Currently in development at Abbott Vascular. Not available for sale in the United States.
Trial website
https://clinicaltrials.gov/show/NCT00856856
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick Serruys, MD
Address 0 0
Erasmus Heart Center, Thorax Centrum
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications