A GLOBAL, MULTICENTER, PROSPECTIVE, REAL WORLD OBSERVATIONAL STUDY FOR LEFT MAIN DISEASE TREATMENT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 42
- 主要终点
- Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular event
研究概览
简要总结
The purpose of this study is to observe clinical courses for long-term in patients with unprotected LMCA disease and to evaluate comparative results of medical treatment, coronary stenting with drug-eluting stents, and CABG for the treatment of an unprotected LMCA stenosis in the "real world" daily practice.
详细描述
This study is a multicenter, large clinical registry to evaluate comparative outcomes of medical therapy, PCI with DES, or CABG for patients with unprotected LMCA stenosis in the Asia-Pacific, as recorded in the MAIN-IRIS Registry. Data will be prospectively collected on approximately 5000 subjects who diagnosed LM disease (>50% by visual estimation) at approximately 65 centers in Korea and Asia-Pacific region. Brief study design is as depicted in the following figure
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Significant unprotected left main stenosis (>50% by visual estimation)
- •The LMCA is considered unprotected if there are no patent coronary artery bypass grafts to the left anterior descending artery or the left circumflex artery.
- •No limitation of clinical or lesion characteristics
- •Age >18 years
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
排除标准
- •Protected left main stenosis
结局指标
主要结局
Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular event
时间窗: 2-year
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.
次要结局
- Death(10-year)
- Myocardial infarction(10-year)
- Target vessel revascularization(10-year)
- Cardiac death(10-year)
- Cerebrovascular event(10-year)
- Target lesion revascularization(10-year)
- Stent thrombosis(10-year)
- Binary restenosis and late luminal loss in both in-stent and in-segment(9-month)
- Rehospitalization(10-year)
研究者
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea