The European Bifurcation Coronary Study; A Randomised Comparison Of Provisional T-Stenting Versus A Systematic Two Stent Strategy In Large Calibre True Bifurcations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Composite primary endpoint (Death, MI, TVR)
研究概览
简要总结
This study will examine use of two-stent versus one-stent techniques for patients with large calibre bifurcation lesions including significant side branch disease.
详细描述
Treatment of bifurcation coronary lesions remains a difficult area, in which best practice is yet to be established. Prior to the era of drug-eluting stents, the limited data which existed suggested that a strategy of stenting the main vessel, with balloon angioplasty alone of the side-branch if required was superior to stenting both vessels.
Randomised trials of "all-comer" bifurcation lesions have now established that there is no advantage to systematic dual drug-eluting stent strategies. However, these trials included patients with no disease in the side branch, and small side branch vessels.
Expert consensus suggests that "large" bifurcations with significant ostial side branch disease still merit a systematic total lesion coverage stent technique. This trial therefore is designed to assess the hypothesis that large true bifurcations with significant side branch ostial disease are more successfully treated with a systematic culotte technique than with the provisional T approach.
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
- •"True" coronary bifurcation lesion (i.e. >50% lesion in both main vessel and side branch) requiring revascularisation
- •Main vessel ≥ 2.5mm diameter (visual inspection)
- •Side branch ≥ 2.5mm diameter (visual inspection)
- •Side branch ostial lesion ≥5mm length
- •Patient ≥18 years old
- •Females of childbearing potential: -ve pregnancy test
排除标准
- •Acute ST elevation myocardial infarction
- •Cardiogenic shock
- •Left main stem lesion of haemodynamic significance
- •Chronic total occlusion of either vessel
- •Additional Type C lesions requiring PCI
- •Either bifurcation vessel not suitable for stenting
- •Platelet count ≤50 x 109/mm3
- •Left ventricular ejection fraction ≤20%
- •Patient life expectancy less than 12 months
- •Known allergies to aspirin, clopidogrel, heparin, stainless steel, intravenous contrast (severe), or stent drug elutant
- •Participation in another investigational drug or device study
- •Patient unable to give informed consent
结局指标
主要结局
Composite primary endpoint (Death, MI, TVR)
时间窗: 12 months
Death Myocardial infarction Target Vessel Revascularisation
次要结局
- Stent thrombosis(12 months)
研究者
David Hildick-Smith
Consultant Cardiologist
Royal Sussex County Hospital