NCT02385279已完成不适用
Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MiStent SES) for Revascularization of Coronary Arteries
ECRI bv24 个研究点 分布在 4 个国家目标入组 1,398 人开始时间: 2015年3月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,398
- 试验地点
- 24
- 主要终点
- Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE)
研究概览
简要总结
The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •All comers" patients:
- •Male or female patients 18 years or older;
- •Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation.
- •The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria.
- •The patient is judged to be capable of providing voluntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.
排除标准
- •Known pregnancy or breastfeeding at time of randomization;
- •Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor;
- •Concurrent medical condition with a life expectancy of less than 12 months.
- •The patient is unwilling/ not able to return for outpatient clinic at 1 month and 12 months follow-up.
- •Currently participating in another trial and not yet at its primary endpoint.
结局指标
主要结局
Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE)
时间窗: 12 months postprocedure
DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization.
次要结局
- All-cause Death(At 12 months)
- MACE(At 12 months)
- Stent Thrombosis(At 12 months)
- Target Vessel Failure (TVF)(At 12 months)
- POCE(At 12 months)
- Myocardial Infarction(At 12 months)
- Any Revascularization(At 12 months)
研究者
研究点 (24)
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