A Prospective, Multicenter, Single arm, Open label, Pilot Clinical Study of MeRes 100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the Treatment of de-novo native Coronary Artery Lesions
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Registration Number
- CTRI/2015/04/005706
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 108
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 <100% with a
TIMI flow of >= 1.
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 < 30%, Cardiac tamponade.
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 <100,000 cells/mm3, a WBC of <3,000 cells/mm3.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Clinical endpoint: <br/ ><br>1. Proportion of population reporting Major Adverse <br/ ><br>Cardiac Events at 6 months from the day of index <br/ ><br>Procedure. <br/ ><br>Primary Safety Endpoints: <br/ ><br>1. Proportion of Population with Ischemia Driven <br/ ><br>MACE at 6 months from the date of Index procedure. <br/ ><br>Primary Angiographic endpoint: <br/ ><br>1. Late lumen loss at 6 months Predetermined <br/ ><br>subgroup of 35% of the overall study population.Timepoint: 6 Months
- Secondary Outcome Measures
Name Time Method