Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: Sirolimus Eluting Bioresorbable Vascular Scaffold System (BVS): Treatment(Per-cutaneous Coronary intervention) of de-novo native coronary artery lesions.â??with Sirolimus Eluting Biores
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1. Subjects between 18 â?? 65 years of age. 2. Subject is able to sign written informed consent form. 3. Subjects with symptomatic Myocardial Ischemia, Chronic Stable Angina. 4. The patient has planned intervention of a single de novo lesion in native epicardial vessel. 5. Subject who is an acceptable candidate for CABG. 6. Subject willing not to participate in any other clinical investigation for a period of 3 years following the index procedure. Angiographic Inclusion Criteria: 1. Subject with maximum two treatable de novo lesions located maximum one per native epicardial vessel located in major artery or branch, with Reference vessel Diameter between 2.5 and 3.5 mm by on line QCA. 2. Target lesion length between 17 and 27 mm. 3. Subjects with Lesion(s), with a visually estimated stenosis of >= 50% and TIMI flow of >= 1.
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. Subjects unable to provide written informed consent. 2. Pregnant or nursing mother and those who plan pregnancy during the clinical investigation (Female patients must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraceptive must be used during participation in this Clinical Investigation). 3. Subjects with known allergy to Poly-lactic Acid, PLLA, PDLG, Nitinol, Contrast media, and any drug in dual antiplatelet therapy including aspirin, both heparin and bivalirudin etc. 4. Subject diagnosed with acute MI (AMI) within 7 days preceding the index procedure, as indicated by elevated levels of Cardiac Enzymes and/or ST segment changes in ECG. 5. Subject with history of previous revascularization procedures including CABG and PCI. 6. Subject with vascular aneurysms, Cardiac arrhythmias, Congestive Cardiac Failure having LVEF 7. Recipient of an organ in an organ transplant procedure or is on a waiting list for any organ transplant. 8. Subjects receiving immunosuppression therapy or having known immunosuppressive or autoimmune disease. 9. Subjects with history of stroke,cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA), renal insufficiency where creatinine levels are more than 1.3 mg/dl, known aplastic anemia, chronic liver disease,platelet count 10. Subjects planned for Elective surgery within the first 12 months after the procedure that will require discontinuing Dual antiplatelet therapy. 11. Subject has a history of bleeding diathesis or coagulatory or will refuse blood transfusion, significant GI or urinary bleed within the past 12 months. 12. Subject having extensive peripheral vascular disease that precludes safe 6 French sheath insertion. 13. Subject having a history of paradoxical exercise induced vasoconstriction that is consistent with myocardial bridging in the coronary anatomy. 14. Subjects participating in another clinical investigation 15. Subjects with short life expectancy such as Cancer, HIV / AIDS, or other comorbid conditions that would limit compliance with the follow-up schedule of the study. Angiographic Exclusion Criteria: 1. Subjects who are non-candidates for PCI. 2. Any of the Target lesions meets any of the following criteria: a) Aorto-ostial location (within 3 mm). b) Lesion located in Left main Coronary Artery. c) Lesion Located within 2 mm of origin of the LAD or LCX. d) Lesion that Involves a bifurcation with a side branch >= 2mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring intervention. e) Total occlusion (TIMI Flow 0), prior to wire crossing. f) Extreme tortuosity proximal to or within the lesion g) Lesions having Heavy calcification. h) Extreme angulation (>=90%) proximal to or within the lesion. 3. Evidence of previous revascularization: a) Previous PCI with or without Restenosis from previous intervention. b) Arterial or venous graft with or without Lesion Located within the graft or distal to a diseased arterial or saphenous vein graft. 4. The target vessel contains visible thrombus. 5. Another (clinically significant or potentially significa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Clinical endpoint: 1. Proportion of population reporting Major Adverse Cardiac Events at 6 months from the day of index Procedure. Primary Safety Endpoints: 1. Proportion of Population with Ischemia Driven MACE at 6 months from the date of Index procedure. Primary Angiographic endpoint: 1. Late lumen loss at 6 months Predetermined subgroup of 35% of the overall study population.Timepoint: 6 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| MSCT Endpoints:Vascular Area and Scaffold areaTimepoint: 12 months;Number of Dissections grade more than B, Residual Stenosis greater than 10%, TIMI flow less than TIMI-III flowTimepoint: Post Procedure;OCT Endpoints:Mean Reference Vessel Diameter and minimum Lumen Diameter in target lesionTimepoint: Pre procedure, Post procedure, 6 and 24 months.;OCT Endpoints:Proportions of struts covered and remaining uncovered,Proportion of struts with persisting analyzable incomplete opposition from baseline,Number and proportion of struts with late incomplete oppositionTimepoint: 6 and 24 montths;Acute Device Success as defined by achieving residual Diameter Stenosis less than 10% before post dilatation.Timepoint: 36 Months;OCT Endpoints:Proportions of struts with complete and insufficient opposition to the vessel wallTimepoint: Post Procedure,6 and 24 months;OCT Endpoints:Vessel area,Analyzable Scaffold area,Lumen area,Minimum, Luminal Area (MLA),Mean Volume obstruction in treated area and segment,Mean Lumen Area in treated area and segmentTimepoint: Post procedure,6 and 24 months.;OCT Endpoints:Vessel wall thickness and neo-intimal thickness,Treated Site % Volume Obstruction (VO)Timepoint: 6 and 24 months;Scaffold thrombosisTimepoint: 1, 6, 12, 24 and 36 months;Target Vessel Failure defined as hierarchical composite of Cardiac Deaths, Target vessel Oriented MI and Target Vessel RevascularizationTimepoint: 1, 6, 12, 24 and 36 months;Target Vessel oriented MI (TV-MI)Timepoint: 1, 6, 12, 24 and 36 months;In Stent and in segment Acute GainTimepoint: Post Procedure;In- treated area and In-segment % Diameter Stenosis (DS) Timepoint: post-procedure, 6 and 24 months.;Acute procedure success as defined by achieving TIMI III grade flow by implantation of device.Timepoint: 1,6,12,24 months;Cardiac deathsTimepoint: 1, 6, 12, 24 and 36 months.;Diameter Stenosis Percent,In-segment LL and In- treated area Late LossTimepoint: 6 and 24 Months;Major Adverse Cardiac Events at defined a | — |
Countries
India
Contacts
Public ContactPrashant Janbandhu
Escorts Heart Institute & Res. Centre
Outcome results
None listed