NCT02932553撤回4 期
BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease: Pilot Study
Seung-Jung Park1 个研究点 分布在 1 个国家开始时间: 2017年4月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Composite of all cause death, myocardial infarction, and angina-related hospitalization
研究概览
简要总结
The purpose of this study is to determine whether BVS(Bioresorbable Vascular Scaffold) implantation with optimal medical therapy can improve the outcome of patients with variant angina and moderate coronary artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Vasospastic angina diagnosed by provocation test including ergonovine provocation coronary angiography or ergonovine echocardiogram
- •No-ischemia producing moderate coronary artery disease(stenosis>50%, FFR>0.8)
排除标准
- •Ischemic coronary lesion
- •Organic heart disease associated with myocardial ischemia or sudden cardiac death
- •History of percutaneous coronary intervention
- •Cerebrovascular diseases or peripheral disease
- •NYHA III and IV
- •Cardiac pacemaker or implantable defibrillator
- •Pregnancy or breast feeding
- •Life expectancy less than 2 years
结局指标
主要结局
Composite of all cause death, myocardial infarction, and angina-related hospitalization
时间窗: 2year
次要结局
- Cardiac death(2year)
- Angina-related hospitalization(2year)
- All cause death(2year)
- Variant angina(2year)
- Scaffold thrombosis(2year)
- Repeat revascularization(2year)
- Myocardial infarction(2year)
- Composite event of death or myocardial infarction(2year)
- Stroke(2year)
- Composite event of cardiac death or myocardial infarction(2year)
研究者
Seung-Jung Park
professor, Division of Cardiology, Department of Internal Medicine
Asan Medical Center
研究点 (1)
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