NCT03190057终止不适用
Evaluation of Effectiveness and Safety of BIOFREEDOM™ FAMILY Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Seung-Jung Park8 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2019年5月20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
- 218
- 试验地点
- 8
- 主要终点
- Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
研究概览
简要总结
The objective of this study is to evaluate effectiveness and safety of BIOFREEDOM™ FAMILY stent in the "real world" daily practice as compared with other drug-eluting stents.
详细描述
BIOFREEDOM™ FAMILY stent means that Biofreedom stent, Biofreedom Ultra and the other stents with names starting with Biofreedom.
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
- •Patient with BIOFREEDOM™ FAMILY stent
- •Written consent
排除标准
- •Intervention with BIOFREEDOM™ FAMILY stent and other drug eluting stent at the same time
- •Life-expectancy less than 1 year
- •Cardiac shock
结局指标
主要结局
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
时间窗: 1 year
次要结局
- Stroke(5 year)
- All cause death(5 year)
- Cardiac death(5 year)
- Myocardial Infarction(5 year)
- Composite event rate of death or myocardial infarction (MI)(5 year)
- Composite event rate of cardiac death or myocardial infarction (MI)(5 year)
- Target- Vessel Revascularization(5 year)
- Target- Lesion Revascularization(5 year)
- Stent thrombosis(5 year)
- Procedural Success rate(5 day)
研究者
Seung-Jung Park
Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine
Asan Medical Center
研究点 (8)
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