CTRI/2015/04/005706已完成2 期
A Prospective, Multicenter, Single arm, Open label, Pilot Clinical Study of MeRes 100Sirolimus Eluting Bioresorbable Vascular Scaffold System in the Treatment of de-novonative Coronary Artery Lesions - MeRes-1
Meril Life Sciences Pvt Ltd0 个研究点目标入组 108 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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.
排除标准
- •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
研究者
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