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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02086006




Registration number
NCT02086006
Ethics application status
Date submitted
10/03/2014
Date registered
13/03/2014
Date last updated
1/02/2018

Titles & IDs
Public title
Elixir Medical Clinical Evaluation of the DESolve Myolimus Eluting Bioresorbable Coronary Stent System - DESolve I Trial
Scientific title
A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATION OF THE DESolveTM MYOLIMUS ELUTING BIORESORBABLE CORONARY STENT SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS
Secondary ID [1] 0 0
ELX-CL-1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 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 - DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

Other: DESolve scaffold - DESolve Novolimus Eluting Bioresorbable Coronary Scaffold. test arm, intervention


Treatment: Devices: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold


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

Outcomes
Primary outcome [1] 0 0
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Timepoint [1] 0 0
1 month
Primary outcome [2] 0 0
Clinically-Indicated Target Lesion Failure (CI-TLF)
Timepoint [2] 0 0
1 month
Primary outcome [3] 0 0
Clinically-Indicated Target Vessel Failure (CI-TVF)
Timepoint [3] 0 0
1 month
Primary outcome [4] 0 0
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Timepoint [4] 0 0
1 month
Primary outcome [5] 0 0
Stent thrombosis
Timepoint [5] 0 0
1 month
Primary outcome [6] 0 0
Acute success - Procedure success - Acute Success is classified according to the following definitions:
Procedure success - Attainment of final result, < 50% residual stenosis of the target site, using the DESolve Myolimus Eluting BCSS device without the occurrence of in-hospital any Major Adverse Cardiac Endpoints.
Timepoint [6] 0 0
7 days
Primary outcome [7] 0 0
Acute success - Device success - Acute Success is classified according to the following definitions:
Device success - Attainment of final result, < 50% residual stenosis of the target site, using the study stent without the need for other non-study stents.
Timepoint [7] 0 0
7 days
Primary outcome [8] 0 0
Stent thrombosis
Timepoint [8] 0 0
6 months
Primary outcome [9] 0 0
Stent thrombosis
Timepoint [9] 0 0
12 months
Primary outcome [10] 0 0
Stent thrombosis
Timepoint [10] 0 0
2 years
Primary outcome [11] 0 0
Stent thrombosis
Timepoint [11] 0 0
3 years
Primary outcome [12] 0 0
Stent thrombosis
Timepoint [12] 0 0
4 years
Primary outcome [13] 0 0
Stent thrombosis
Timepoint [13] 0 0
5 years
Primary outcome [14] 0 0
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Timepoint [14] 0 0
6 months
Primary outcome [15] 0 0
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Timepoint [15] 0 0
12 months
Primary outcome [16] 0 0
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Timepoint [16] 0 0
2 years
Primary outcome [17] 0 0
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Timepoint [17] 0 0
3 years
Primary outcome [18] 0 0
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Timepoint [18] 0 0
4 years
Primary outcome [19] 0 0
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
Timepoint [19] 0 0
5 years
Primary outcome [20] 0 0
Clinically-Indicated Target Lesion Failure (CI-TLF)
Timepoint [20] 0 0
6 months
Primary outcome [21] 0 0
Clinically-Indicated Target Lesion Failure (CI-TLF)
Timepoint [21] 0 0
12 months
Primary outcome [22] 0 0
Clinically-Indicated Target Lesion Failure (CI-TLF)
Timepoint [22] 0 0
2 years
Primary outcome [23] 0 0
Clinically-Indicated Target Lesion Failure (CI-TLF)
Timepoint [23] 0 0
3 years
Primary outcome [24] 0 0
Clinically-Indicated Target Lesion Failure (CI-TLF)
Timepoint [24] 0 0
4 years
Primary outcome [25] 0 0
Clinically-Indicated Target Lesion Failure (CI-TLF)
Timepoint [25] 0 0
5 years
Primary outcome [26] 0 0
Clinically-Indicated Target Vessel Failure (CI-TVF)
Timepoint [26] 0 0
6 months
Primary outcome [27] 0 0
Clinically-Indicated Target Vessel Failure (CI-TVF)
Timepoint [27] 0 0
12 months
Primary outcome [28] 0 0
Clinically-Indicated Target Vessel Failure (CI-TVF)
Timepoint [28] 0 0
2 years
Primary outcome [29] 0 0
Clinically-Indicated Target Vessel Failure (CI-TVF)
Timepoint [29] 0 0
3 years
Primary outcome [30] 0 0
Clinically-Indicated Target Vessel Failure (CI-TVF)
Timepoint [30] 0 0
4 years
Primary outcome [31] 0 0
Clinically-Indicated Target Vessel Failure (CI-TVF)
Timepoint [31] 0 0
5 years
Primary outcome [32] 0 0
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Timepoint [32] 0 0
6 months
Primary outcome [33] 0 0
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Timepoint [33] 0 0
12 months
Primary outcome [34] 0 0
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Timepoint [34] 0 0
2 years
Primary outcome [35] 0 0
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Timepoint [35] 0 0
3 years
Primary outcome [36] 0 0
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Timepoint [36] 0 0
4 years
Primary outcome [37] 0 0
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
Timepoint [37] 0 0
5 years

Eligibility
Key inclusion criteria
- Patient must be at least 18 years of age

- Patient is able to verbally confirm understanding of risks, benefits and treatment
alternatives of receiving the DESolve Myolimus Eluting BCSS and he/she or his/her
legally authorized representative provides written informed consent, as approved by
the appropriate Ethics Committee of the respective clinical site, prior to any
clinical study related procedure

- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina,
silent ischemia, positive functional study electrocardiogram (ECG) changes consistent
with ischemia)

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

- Patient must agree to undergo all clinical study required follow-up visits,
angiograms, IVUS, OCT and MSCT

- Patient must agree not to participate in any other clinical study for a period of two
years following the index procedure
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients has a known diagnosis of acute myocardial infarction (AMI) within 72 hours
preceding the index procedure and CK and CK-MB have not returned within normal limits
at the time of procedure

- The patient is currently experiencing clinical symptoms consistent with AMI

- Patient has current unstable arrhythmias Patient has undergone previous percutaneous
interventions for lesions in either a non-target vessel or target vessel Patient has
undergone previous percutaneous interventions for lesions in either a non-target
vessel or target vessel

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

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

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

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

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

- Patient has a known hypersensitivity or contraindication to aspirin, both heparin and
bivalirudin, both clopidogrel and ticlopidine, Myolimus, PLLA polymers or contrast
sensitivity that cannot be adequately pre-medicated

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

- Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of <
3,000 cells/mm3, or documented or suspected liver disease.

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

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

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

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

- Patient has extensive peripheral vascular disease that precludes safe 7 French sheath
insertion

- 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 study plan, confound the data interpretation or is
associated with a limited life expectancy (i.e., less than one year)

- Patient is already participating in another clinical study

- Women of childbearing potential who have not undergone surgical sterilization or is
not post-menopausal (defined as amenorrheic for at least one year)

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)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Elixir Medical Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with
single de novo, Type A lesions < 10 mm in length and located in a native coronary artery with
a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline QCA and IVUS. All
patients will receive a 3.0 x 14mm DESolve Stent loaded with approximately 40 mcg of
Myolimus.

- Angiographic and intravascular ultrasound (IVUS) will be completed for all patients at
baseline and at 6 months.

- Optical Coherence Tomography (OCT) will will be completed for all patients at baseline
and at 6 months.

- Multi-slice computed tomography (MSCT) will be conducted on all patients enrolled at 12
and 24 months.
Trial website
https://clinicaltrials.gov/show/NCT02086006
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Ormiston, MD
Address 0 0
Auckland City Hospital and Mercy Angiography Unit
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