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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02086006
Ethics application status
Date submitted
10/03/2014
Date registered
13/03/2014
Date last updated
7/09/2023

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
Other: DESolve scaffold - DESolve Novolimus Eluting Bioresorbable Coronary Scaffold. test arm, intervention
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
Timepoint [6] 0 0
7 days
Primary outcome [7] 0 0
Acute success - Device success
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
Sex
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
Not applicable
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
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2017
Sample size
Target
Accrual to date
Final
16
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02086006