NCT02593994进行中（未招募）不适用
Evaluation of Effectiveness and Safety of Resolute Onyx™ and Onyx Frontier™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Seung-Jung Park31 个研究点 分布在 1 个国家目标入组 4,500 人开始时间: 2015年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,500
- 试验地点
- 31
- 主要终点
- Stent thrombosis
研究概览
简要总结
The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent compared to other (drug eluting stents) DES.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 and more
- •Intervention with Onyx Drug Eluting Stent
- •Agreed with written informed consent form
排除标准
- •Intervention with Onyx drug eluting coronary stent and other drug eluting stent at the same time
- •Life expectancy of 1year and under
- •Cardiac shock
研究组 & 干预措施
Onyx Drug Eluting Stent
干预措施: Onyx Drug Eluting Stent group (Device)
结局指标
主要结局
Stent thrombosis
时间窗: 1 year
As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis
次要结局
- Target Lesion revascularization(5 year)
- Composite event rate(5 year)
- Myocardial infarction(5 year)
- Composite event of cardiac death or myocardial infarction(5 year)
- All death(5 year)
- Cardiac death(5 year)
- Procedural success(3 day)
- Target Vessel revascularization(5 year)
- Stent thrombosis(5 year)
- Composite event of death or myocardial infarction(5 year)
- Stroke(5 year)
研究者
Seung-Jung Park
MD, PhD
Asan Medical Center
研究点 (31)
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