Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: MeRes100ââ??¢ BRS: The MeRes100ââ??¢ Sirolimus-eluting BioResorbable Vascular Scaffold System (BRS) is indicated for improving coronary luminal diameter in patients with symptomatic
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1. Male or female patient �18 years of age 2. Subject who has provided written informed consent 3. Subject must agree to undergo all clinical investigations and follow-up visits as per protocol 4. Subject with documented myocardial ischemia (e.g., stable, unstable angina, or silent ischemia) and who are eligible candidates for elective percutaneous coronary intervention (PCI) 5. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure. This includes clinical trials of medications and/or invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed Angiographic Inclusion Criteria: 1. One de novo target lesion or up-to two de novo target lesions in different epicardial vessels: Different epicardial vessels are defined as left anterior descending artery (LAD) and its branches, left circumflex artery (LCX) arteries and its branches, and right coronary arteries (RCA) and its branches. Thus, for example, the subject must not have two target lesions required to be treated at the LAD and its branches at the same time 2. Each target lesion can be fully covered by one scaffold 3. Target lesion with angiographic evidence of �70% stenosis (by visual estimation) and �50% (by QCA estimation) with TIMI flow of �1. If the target lesion is 4. Target lesion(s) located in native coronary artery with reference vessel diameter (RVD) of �2.75 mm to �4.0 mm and length �34 mm by QCA or by visual estimation
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel, ticlopidine inclusive), everolimus, sirolimus or its analog or derivative, poly (L-lactide), poly (DL-lactide), cobalt, PLGA [poly(DL-lactide-co-glycolide)], chromium, nickel, tungsten, stainless steel, platinum, platinum-chromium alloy, iron, molybdenum, amorphous silicon carbide, acrylic and fluoropolymers or contrast sensitivity that cannot be adequately pre-medicated 2. Any PCI 3. Previous CABG or PCI in the target vessel(s) 4. Left ventricular ejection fraction (LVEF) evaluated during hospitalization or during index procedure but prior to randomization for confirming the subjectââ?¬•s eligibility 5. Concurrent medical condition with less than three years of life expectancy 6. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months of baseline visit 7. Renal insufficiency as estimated by Glomerular Filtration Rate (GFR) 8. Subject with cardiac arrhythmia detected at the time of screening 9. Subject is on immunosuppressant therapy and has immunosuppressive or autoimmune disease 10. Subject with hepatic disorder or chronic liver disease, known aplastic anaemia, platelet count 700,000 cells/mm3, a WBC of 11. Subject with prior brachytherapy of the target lesion or use of brachytherapy for the treated site restenosis 12. Subject has a history of bleeding diathesis or coagulatory disease, refuses blood transfusion, significant gastrointestinal or urinary bleed within the past 12 months 13. Subject who underwent or needs organ transplant 14. Planned PCI for any clinically significant lesion after index procedure 15. Planned surgery within 12 months after index procedure 16. Pregnant or nursing subject and those who plan pregnancy in the period until 5 years following index procedure (Female subject of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and contraception must be used during participation in this trial) 17. Any newly onset acute myocardial infarction within 1 week ( 18. Subject with significant peripheral vascular disease that precludes safe access to sheath or catheter Angiographic Exclusion Criteria: 1. Target lesion located within 3 mm of the origin of the LAD or LCx 2. Target lesion involving a bifurcation lesion with side branch ââ?°Â¥2 mm in diameter 3. Highly calcified lesions <
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion failureTimepoint: Time frame: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular DeathTimepoint: [Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years];Clinically Driven Target Lesion RevascularizationTimepoint: [Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years];Device SuccessTimepoint: [Time Frame: At index procedure];Optical Coherence Tomography (OCT) SubsetTimepoint: [Time Frame: Post-procedure, 1 year, 3 years and 5 years];Procedure SuccessTimepoint: [Time Frame: Till discharge];Quality of Life (QoL)Timepoint: [Time Frame: Baseline, 30 days and 1 year];Quantitative Coronary Angiography (QCA) SubsetTimepoint: [Time Frame: Post-procedure, 1 year, 3 years and 5 years];Scaffold/Stent Thrombosis RateTimepoint: [Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years];Target Lesion FailureTimepoint: [Time Frame: 30 days, 6 months, 2 years, 3 years, 4 years and 5 years];Target Vessel Failure (TVF)Timepoint: [Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years];Target Vessel Myocardial InfarctionTimepoint: [Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years];Target Vessel Revascularization (TVR)Timepoint: [Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years] | — |
Countries
Bulgaria, Croatia, Denmark, France, Hungary, India, Indonesia, Italy, Latvia, Netherlands, Romania, Serbia, Slovakia, Spain, Sweden, Ukraine
Contacts
Public ContactDr Ashok Thakkar
Meril Life Sciences Pvt. Ltd.
Outcome results
None listed