Coronary Artery Bifurcation Revascularization Without kIssing ballOon infLation by rEpoT: The CABRIOLET Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.
研究概览
简要总结
The presence of a coronary bifurcation complicates percutaneous revascularization. Bifurcation stenting needs to take into account the difference of diameter between proximal and distal vessels and the necessity to limit the side branch obstruction. Provisional stenting techniques with balloon juxtaposition as Kissing Balloon Inflation (KBI) fail to demonstrate a clinical benefits. This is probably explain by the detrimental effect during these technics on the proximal segment with an arterial overstretch. A new sequential technique, named rePOT, demonstrated experimentally a mechanical superiority compared to juxtaposition balloon techniques included KBI. RePOT associates an initial proximal optimizing technique (POT), a side branch inflation and a final POT.
A first clinical study (n=106 patients) confirmed these excellent mechanical results with serial OCT analysis and demonstrated an excellent short term safety. Since 2017, rePOT is recommended in Europe in clinical practice.
This large registry is dedicated to confirm the clinical benefits at long term after bifurcation revascularization with rePOT technique before a large randomise trial.
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
- •Discovery, during angiography, of a significant coronary lesion (by angiographic or functional assessment) including a bifurcation under a provisional stenting strategy. Bifurcation have to be significant according to the operator and the coronary anatomy (but the side branch diameter have to be greater than 1.75mm)
- •Stable lesion without high thrombus burden
- •Patient agreement to study participation and ≥ 18 years
排除标准
- •Complex lesion or anatomy requiring revascularization strategy with more than one stent
- •Contraindication to a double platelet anti-aggregation ≥ 6mois (recommended implantation of active stent)
- •Unstable patient according to the operator (used of hemodynamic drug support, mechanical ventilation)
- •Indication of cardiac surgery.
- •Lesion culprit in ST- or non ST-elevation myocardial infarction <12h.
- •High thrombus burden in angiography or endocoronary imaging (IVUS, OCT).
- •Pregnancy, loose of legal right
- •Other interventional study participation <30 jours.
结局指标
主要结局
Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.
时间窗: At 12 months
Number of target lesion revascularization
次要结局
未报告次要终点