NCT02622100终止不适用
Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Duk-Woo Park, MD14 个研究点 分布在 1 个国家目标入组 629 人开始时间: 2016年2月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 629
- 试验地点
- 14
- 主要终点
- Composite event
研究概览
简要总结
The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold 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 Bioresorbable Vascular Scaffold
- •Agreed with written informed consent form
排除标准
- •Bypass graft surgery (CABG) recommended
- •Lesion with previous bypass graft surgery (CABG)
- •Severe calcification and/or severe tortuosity
- •Contraindication to antiplatelet agent or Inability to take dual antiplatelet therapy within 1 year
- •Life expectancy of 1year and under
- •Subjects scheduled to receive cardiac surgery or serious non-cardiac surgery
- •Cardiac shock
结局指标
主要结局
Composite event
时间窗: 1 year
The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)
次要结局
- cardiac death(5 years)
- Composite event of death or myocardial infarction(5 years)
- Stroke(5 years)
- all death(5 years)
- myocardial infarction(5 years)
- Target Vessel revascularization(5 years)
- Composite event of cardiac death or myocardial infarction(5 years)
- Target Lesion revascularization(5 years)
- Stent thrombosis(5 years)
- Procedural success(3 days)
研究者
Duk-Woo Park, MD
Principal investigator
Asan Medical Center
研究点 (14)
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