Non-inferiority Clinical Trial to Compare the Safety and Performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System Versus Contemporary DES Platforms in Patients With de Novo Coronary Artery Lesions

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 \<6 months prior to the index procedure
• •3. Previous CABG or PCI in the target vessel(s)
• •4. Left ventricular ejection fraction (LVEF) \<30% as evaluated by any non-invasive imaging method including but not limited to, echocardiogram, angiography, Magnetic Resonance Imaging (MRI), Multiple-Gated Acquisition (MUGA) scan, radionuclide ventriculography, Positron Emission Tomography (PET) scan, etc. For subjects with stable Coronary Artery Disease (CAD), LVEF may be obtained within 6 months prior to the procedure. For Acute coronary syndrome (ACS) subjects, LVEF must be evaluated during hospitalization or during index procedure but prior to randomization for confirming the subject'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) \<30 ml/min/1.73m2 or dialysis at the time of screening or creatinine level is more than 1.5 mg/dl
• •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 \<100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3
• •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 (\<7days) or, myocardial enzyme has not returned to normal level (clinically non-significant) after myocardial infarction.
• •18. Subject with significant peripheral vascular disease that precludes safe access to sheath or catheter
• •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 ≥2 mm in diameter
• •3. Highly calcified lesions Classification of calcification: moderate calcification - discontinuous dotted high density image; severe calcification - continuous high density image around the whole vessel wall under continuous X ray by multiple positions.
• •4. Target lesion which prevents complete balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
• •1. Residual % Diameter Stenosis (DS) is \< 40% (per visual estimation), (≤ 20% is strongly recommended).
• •2. TIMI Grade-3 flow (per visual estimation).
• •3. No angiographic complications (e.g., no-reflow, distal embolization, side branch closure).
• •4. No dissections NHLBI grade D-F.
• •5. No chest pain lasting \> 5 minutes.
• •6. No ST depression or elevation lasting \> 5 minutes
• •5. Total occlusion (TIMI flow 0), prior to wire crossing
• •6. Excessive tortuosity (≥ two 45° angles), or extreme angulation (≥90°) proximal to or within the target lesion
• •7. Lesion is located in left main coronary artery
• •8. Thrombus in the target vessel determined by angiography or OCT
• •9. Subject with three-vessel disease where all three vessels require intervention
• •10. Additional lesion in same coronary vessel which requires treatment
• •11. Evidence of previous revascularization
• •1. Previous PCI with or without restenosis from previous intervention
• •2. Arterial or venous graft with or without lesion located within the graft or distal to a diseased arterial or saphenous vein graft Note: Lesions within 3 mm of the origin of the right coronary artery may be treated