NCT02497014Unknown不适用
The European Bifurcation Club Left Main Study: A Randomised Comparison of Single Versus Dual Stent Implantation for Distal Left Main True Coronary Bifurcation Lesions
European Cardiovascular Research Center47 个研究点 分布在 8 个国家目标入组 450 人开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 450
- 试验地点
- 47
- 主要终点
- Composite of Death, Myocardial infarction and Target Lesion Revascularisation
研究概览
简要总结
The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must meet ALL of the inclusion criteria:
- •Bifurcation distal left main stem stenosis >50% and
- •Ischaemic symptoms, or
- •Positive non-invasive imaging for ischaemia, or
- •Positive FFR, or
- •LMS IVUS MLA <6mm2
- •Left main diameter ≤5.75mm
- •True bifurcation lesion type 1,1,1 or 0,1,1
- •LAD and Cx diameter both >2.75mm
- •Unprotected left main
- •Patient ≥18 years old
排除标准
- •STEMI <72 hours preceding
- •Cardiogenic shock
- •Chronic total occlusion of either vessel
- •>2 other coronary lesions planned for treatment
- •SYNTAX score for planned lesions to be treated >32
- •LMS trifurcation if all vessels are ≥2.75mm diameter
- •Either bifurcation vessel not suitable for stenting
- •Platelet count ≤50 x 10^9/mm3
- •Left ventricular ejection fraction ≤20%
- •Patient life expectancy less than 12 months
- •Participation in another investigational drug or device study
- •Patient unable to give informed consent
- •Women of child-bearing potential or lactating
结局指标
主要结局
Composite of Death, Myocardial infarction and Target Lesion Revascularisation
时间窗: 1 year
次要结局
- Myocardial Infarction(3 years)
- Stent thrombosis(1 year)
- Angina status(1 year)
- Death(3 years)
- Target Lesion Revascularization(3 years)
研究者
研究点 (47)
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