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
- 1
- 主要终点
- The primary objective is measured in terms of major cardiac and cerebrovascular event (MACCE)-free survival at two year follow-up after index treatment.
研究概览
简要总结
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 10000 subjects who diagnosed LM disease (>50% by visual estimation) at approximately 65 centers in Korea and Asia-Pacific region.
The primary objective 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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Significant unprotected left main stenosis (>50% by visual estimation) â—¦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.
- •â€¢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
- •â€¢Protected left main stenosis.
结局指标
主要结局
The primary objective is measured in terms of major cardiac and cerebrovascular event (MACCE)-free survival at two year follow-up after index treatment.
时间窗: 2year
ï‚ŸNon-fatal myocardial infarction (Q wave and non-Q wave)
时间窗: 2year
ï‚ŸTarget vessel revascularization (TVR) either percutaneous or surgical treatment
时间窗: 2year
ï‚ŸDeath (all-cause mortality)
时间窗: 2year
ï‚ŸStroke
时间窗: 2year
次要结局
- ï‚ŸAll cause death.(ï‚ŸCardiac death.)