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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00967902




Registration number
NCT00967902
Ethics application status
Date submitted
26/08/2009
Date registered
27/08/2009
Date last updated
28/03/2016

Titles & IDs
Public title
Safety and Effectiveness Study of Combo Bio-engineered Sirolimus Eluting Stent
Scientific title
The REMEDEE Study: A Prospective, Randomized Study to Evaluate the Safety and Efficacy of an Abluminal Sirolimus Coated Bio-engineered Stent (Combo Bio-engineered Sirolimus Eluting Stent)
Secondary ID [1] 0 0
VP-0427
Universal Trial Number (UTN)
Trial acronym
REMEDEE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Lesions 0 0
Coronary Artery Lesions 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - coronary stenting
Treatment: Devices - coronary stenting

Experimental: Combo - The Combo Stent is composed of the OrbusNeich R stentâ„¢, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.

Active Comparator: Taxus® Liberté® Stent - Commercially available product

Experimental: Combo - The Combo Stent is composed of the OrbusNeich R stentâ„¢, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.

Active Comparator: Taxus® Liberté® Stent - Commercially available product


Treatment: Devices: coronary stenting
Balloon dilatation of obstructive coronary artery disease with deployment of a metallic stent to scaffold the dilated lesion; stent incorporating sustained release of anti-proliferative agent to control neointimal proliferation and reocclusion; test device incorporates affinity surface for circulating EPCs

Treatment: Devices: coronary stenting
Balloon dilatation of obstructive coronary artery disease with deployment of a metallic stent to scaffold the dilated lesion; stent incorporating sustained release of anti-proliferative agent to control neointimal proliferation and reocclusion; test device incorporates affinity surface for circulating EPCs

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

Outcomes
Primary outcome [1] 0 0
In-stent late lumen loss of the Combo Stent compared to the TAXUS® Liberté® DES
Timepoint [1] 0 0
9 months post-procedure.
Primary outcome [2] 0 0
In-stent late lumen loss of the Combo Stent compared to the TAXUS® Liberté® DES
Timepoint [2] 0 0
9 months post-procedure.
Secondary outcome [1] 0 0
All-cause and cardiac mortality
Timepoint [1] 0 0
30 days, 9 months, 1, 2, 3, 4, and 5 year
Secondary outcome [2] 0 0
Myocardial infarction: Q-wave and non Q-wave, cumulative and individual
Timepoint [2] 0 0
30 days, 9 months, 1, 2, 3, 4, and 5 years
Secondary outcome [3] 0 0
Major Adverse Cardiac Event (MACE) defined as a composite of death, MI (Q-wave or non Q-wave), emergent CABG, or target lesion revascularization by repeat PTCA or CABG
Timepoint [3] 0 0
Hospital discharge, 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure
Secondary outcome [4] 0 0
Vascular complications from index procedure
Timepoint [4] 0 0
Up to hospital discharge
Secondary outcome [5] 0 0
Rate of stent thrombosis, per ARC definition of definite and probable stent thrombosis further categorized as early, late or very late
Timepoint [5] 0 0
30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure
Secondary outcome [6] 0 0
Change in human anti-murine antibody (HAMA) plasma levels
Timepoint [6] 0 0
30 day and 9 month follow-up compared to baseline
Secondary outcome [7] 0 0
Device success, defined as attainment of <50% residual stenosis of the target lesion using the Combo Stent
Timepoint [7] 0 0
Index procedure
Secondary outcome [8] 0 0
Lesion success defined as attainment of < 50% residual stenosis using any percutaneous method
Timepoint [8] 0 0
Index procedure
Secondary outcome [9] 0 0
Procedure success defined as lesion success without the occurrence of in-hospital MACE
Timepoint [9] 0 0
Up to hospital discharge
Secondary outcome [10] 0 0
Clinically (ischemia)-driven target lesion revascularization
Timepoint [10] 0 0
30 days, 9 months, 1, 2, 3, 4 and 5 years
Secondary outcome [11] 0 0
Clinically (ischemia)-driven target vessel revascularization
Timepoint [11] 0 0
30 days, 9 months, 1, 2, 3, 4 and 5 years
Secondary outcome [12] 0 0
In-stent and in-segment angiographic binary restenosis
Timepoint [12] 0 0
9 months
Secondary outcome [13] 0 0
In-stent and in-segment minimum lumen diameter (MLD)
Timepoint [13] 0 0
9 months
Secondary outcome [14] 0 0
In-stent, proximal and distal late lumen loss
Timepoint [14] 0 0
9 months
Secondary outcome [15] 0 0
Neointimal hyperplasia volume and % in-stent volume obstruction as measured by intravascular ultrasound (IVUS) for patients receiving angiographic/IVUS follow-up
Timepoint [15] 0 0
9 months
Secondary outcome [16] 0 0
Target lesion failure (TLF) (defined as death, MI and ischemic target lesion revascularization (TLR))
Timepoint [16] 0 0
30 days, 9 months, 1, 2, 3, 4 and 5 years
Secondary outcome [17] 0 0
All-cause and cardiac mortality
Timepoint [17] 0 0
30 days, 9 months, 1, 2, 3, 4, and 5 year
Secondary outcome [18] 0 0
Myocardial infarction: Q-wave and non Q-wave, cumulative and individual
Timepoint [18] 0 0
30 days, 9 months, 1, 2, 3, 4, and 5 years
Secondary outcome [19] 0 0
Major Adverse Cardiac Event (MACE) defined as a composite of death, MI (Q-wave or non Q-wave), emergent CABG, or target lesion revascularization by repeat PTCA or CABG
Timepoint [19] 0 0
Hospital discharge, 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure
Secondary outcome [20] 0 0
Vascular complications from index procedure
Timepoint [20] 0 0
Up to hospital discharge
Secondary outcome [21] 0 0
Rate of stent thrombosis, per ARC definition of definite and probable stent thrombosis further categorized as early, late or very late
Timepoint [21] 0 0
30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure
Secondary outcome [22] 0 0
Change in human anti-murine antibody (HAMA) plasma levels
Timepoint [22] 0 0
30 day and 9 month follow-up compared to baseline
Secondary outcome [23] 0 0
Device success, defined as attainment of <50% residual stenosis of the target lesion using the Combo Stent
Timepoint [23] 0 0
Index procedure
Secondary outcome [24] 0 0
Lesion success defined as attainment of < 50% residual stenosis using any percutaneous method
Timepoint [24] 0 0
Index procedure
Secondary outcome [25] 0 0
Procedure success defined as lesion success without the occurrence of in-hospital MACE
Timepoint [25] 0 0
Up to hospital discharge
Secondary outcome [26] 0 0
Clinically (ischemia)-driven target lesion revascularization
Timepoint [26] 0 0
30 days, 9 months, 1, 2, 3, 4 and 5 years
Secondary outcome [27] 0 0
Clinically (ischemia)-driven target vessel revascularization
Timepoint [27] 0 0
30 days, 9 months, 1, 2, 3, 4 and 5 years
Secondary outcome [28] 0 0
In-stent and in-segment angiographic binary restenosis
Timepoint [28] 0 0
9 months
Secondary outcome [29] 0 0
In-stent and in-segment minimum lumen diameter (MLD)
Timepoint [29] 0 0
9 months
Secondary outcome [30] 0 0
In-stent, proximal and distal late lumen loss
Timepoint [30] 0 0
9 months
Secondary outcome [31] 0 0
Neointimal hyperplasia volume and % in-stent volume obstruction as measured by intravascular ultrasound (IVUS) for patients receiving angiographic/IVUS follow-up
Timepoint [31] 0 0
9 months
Secondary outcome [32] 0 0
Target lesion failure (TLF) (defined as death, MI and ischemic target lesion revascularization (TLR))
Timepoint [32] 0 0
30 days, 9 months, 1, 2, 3, 4 and 5 years

Eligibility
Key inclusion criteria
General Inclusion Criteria

- The patient must be =18 and = 80 years of age;

- Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, IIB, IIC,
IIIB, IIIC, and/or objective evidence of myocardial ischemia);

- Acceptable candidate for CABG;

- The Patient is willing to comply with specified follow-up evaluations;

- The Patient or legally authorized representative has been informed of the nature of
the study, agrees to its provisions and has been provided written informed consent,
approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board
(IRB), or Human Research Ethics Committee (HREC).

Angiographic

- Single de novo or non-stented restenotic lesion in the target vessel;

- Patients with two-vessel coronary disease, may have undergone successful treatment
(<20% diameter stenosis by visual estimate) of the non-target vessel with approved
devices up to and including the index procedure but must be prior to the index target
vessel treatment. Any non-target vessel or lesion intended to be treated during the
index procedure, cannot be an unprotected left main, ostial lesion, chronic total
occlusion (CTO), heavily calcified, bifurcation, vein grafts, have angiographic
evidence of thrombus, be anything requiring atherectomy, thrombectomy, or
pre-treatment with anything other than balloon angioplasty;

- Target lesion located in a native coronary artery;

- Target lesion (maximum length is 20 mm by visual estimate) covered by a single stent
maximum 23 mm length for Combo Stent, and 24 mm in length for TAXUS® Liberté® (stent
coverage including at least 3 mm of healthy vessel is recommended). The lesion length
should be measured after pre-dilation procedure;

- Reference vessel diameter must be =2.5 to = 3.5 mm by visual estimate. The vessel
diameter should be measured after pre-dilation procedure and after intra-coronary
nitroglycerin if spasm is suspected;

- Target lesion =50% and <100% stenosed by visual estimate.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General

- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year
following index procedure. Female patients of child-bearing potential must have a
negative pregnancy test done within 7 days prior to the index procedure per site
standard test;

- Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours
preceding the index procedure (elevated troponin or CK-MB =2 times upper limit of
normal) or >72 hours preceding the index procedure and CK and CK-MB have not returned
to within normal limits at the time of procedure;

- The patient is currently experiencing clinical symptoms consistent with new onset AMI,
such as nitrate unresponsive prolonged chest pain;

- Impaired renal function (serum creatinine >2.0 mg/dL or 177 µmol/l) or on dialysis;

- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3;

- Patient has a history of bleeding diathesis or coagulopathy or patients in whom
anti-platelet and/or anticoagulant therapy is contraindicated;

- Patient requires low molecular weight heparin (LMWH) treatment post-procedure or has
received a dose of LMWH =8 hours prior to index procedure;

- Patient has received any organ transplant or is on a waiting list for any organ
transplant;

- Patient has other medical illness (e.g., cancer, known malignancy, or congestive heart
failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may
cause non-compliance with the protocol, confound the data interpretation or is
associated with a limited life expectancy (i.e., less than 1 year);

- Patient has a known hypersensitivity or contraindication to aspirin,
heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy,
sirolimus, paclitaxel and/or contrast sensitivity that cannot be adequately
pre-medicated;

- Patient has previously received murine therapeutic antibodies and exhibited
sensitization through the production of Human Anti-Murine Antibodies (HAMA);

- Patient presents with cardiogenic shock;

- Patient has current unstable cardiac arrhythmias that create hemodynamic instability;

- Patient has extensive peripheral vascular disease that precludes safe 6 French sheath
insertion;

- Any significant medical condition which in the Investigator's opinion may interfere
with the patient's optimal participation in the study;

- Currently participating in another investigational drug or device study or patient in
inclusion in another investigational drug or device study during follow-up;

Angiographic

- Unprotected left main coronary artery disease with =50% stenosis;

- Ostial target lesion(s);

- Totally occluded target vessel (TIMI flow 0);

- Calcified target lesion(s) which cannot be successfully predilated;

- Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;

- Angiographic evidence of thrombus in the target lesion(s);

- Target lesion involving bifurcation with a side branch =2.0 mm in diameter (either
stenosis of both main vessel and major side branch or stenosis of just major side
branch) that would require intervention of diseased side branch;

- A significant (>50%) stenosis proximal or distal to the target lesion that cannot be
covered by same single stent;

- Diffuse distal disease to target lesion with impaired runoff;

- Left ventricular ejection fraction (LVEF) =30% (LVEF must be obtained within 6 months
prior to the index procedure);

- Pre-treatment with devices other than balloon angioplasty;

- Prior stent within 10 mm of target lesion;

- Intervention (PCI or bypass) of another lesion performed within 6 months before or
planned within 30 days following the index procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 2
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)
NSW
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment postcode(s) [1] 0 0
2300 - Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OrbusNeich
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting
Stent (Combo Stent) compared to the Taxus® Liberté® Stent in the treatment of coronary artery
lesions.
Trial website
https://clinicaltrials.gov/show/NCT00967902
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian T Meredith, MBBS, PhD
Address 0 0
Monash University
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