NCT02901353Unknown不适用
A Prospective, Single-arm, Multi-centre, Observational, Real World Registry to Evaluate Safety and Performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for Very Long Coronary Lesions.
Meril Life Sciences Pvt. Ltd.5 个研究点 分布在 4 个国家目标入组 400 人开始时间: 2017年2月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 5
- 主要终点
- Freedom of target lesion failure
研究概览
简要总结
A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.
详细描述
Title:
A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.
Short Title:
Morpheus - Global Registry Sponsor: Meril Life Sciences Pvt. Ltd
Device Used:BioMime™ Morph Sirolimus Eluting Coronary Stent System
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be at least 18 years of age.
- •Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of ≤56mm.
- •The patient or guardian agrees to the protocol requirements and the schedule of follow-up and provides informed written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site -
排除标准
- •Patients contraindicated to any of the following medications: aspirin, heparin, clopidogrel, cobalt-chromium, contrast agents and sirolimus.
- •An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrolment.
- •Patients who are actively participating in another drug or device investigational study.
结局指标
主要结局
Freedom of target lesion failure
时间窗: TLF upto 24 months
composite of cardiac death, myocardial infarction and target lesion revascularization.
次要结局
- Academic Research Consortium (ARC) defined stent thrombosis(1, 6, 12 and 24 month)
- MACE(1, 6, 12 and 24 month)
- Target vessel failure(1, 6, 12 and 24 month)
研究者
研究点 (5)
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