NCT02038660招募中不适用
Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study
Seung-Jung Park9 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 9
- 主要终点
- Composite Event
研究概览
简要总结
The purpose of this study is to evaluate long-term effectiveness and safety of patients with coronary disease treated with drug eluting balloon in real world practice.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After pre dilatation residual stenosis 30% and less and also without vessel dissection interrupted blood flow
- •Age 20 and more
- •Treated with Balloon angioplasty
- •Signed informed consent and agreed to follow protocol
排除标准
- •Allergy to paclitaxel, antiplatelet
- •History of side effect to heparin, aspirin, thienopyridines
- •History of bleeding tendency, coagulation disorder, blood transfusion reaction
结局指标
主要结局
Composite Event
时间窗: 1year
Death, Non-fatal myocardial infarction, Target vessel revascularization
次要结局
- All cause death(5year)
- Myocardial infarction(5year)
- Composite event(5year)
- Target vessel revascularization(5year)
- Target lesion revascularization(5year)
- Stent thrombosis(5year)
- Stroke(5year)
- Cardiac death(5year)
- Procedural Success(3day)
研究者
Seung-Jung Park
MD,PhD
Asan Medical Center
研究点 (9)
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