A Randomized, Prospective, Post-market, Multicenter Study to Evaluate the Potential Benefit of Side Branch Ballooning, in the Setting of Single Stenting With Systematic Proximal Optimization Technique, in the Treatment of Bifurcation Lesion
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ceric Sàrl
- 入组人数
- 596
- 试验地点
- 31
- 主要终点
- Periprocedural Myocardial infarction
研究概览
简要总结
KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation PCI procedures for Side Branch protection
详细描述
In the treatment of bifurcation lesion, the role of side branch intervention for improving the safety of Percutaneous Coronary Intervention (PCI), when MB is treated according to the Murray law with a Proximal Optimization Technique (POT), remains unclear.
The KISS study will evaluate the non-inferiority of no side branch intervention versus side branch ballooning, in the setting of single stenting with systematic proximal optimization technique.
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
- •Coronary artery disease requiring revascularization that is amenable to percutaneous coronary intervention (PCI)
- •Any de novo Medina type bifurcation lesion with >70% lesion in the main vessel by visual assessment except Medina 0,0,1 if the planned strategy does not include a main branch stenting
- •Side branch diameter compatible with a PCI with stent implantation (≥ 2.25mm)
- •Side branch requiring a protection wire according to operator evaluation
- •Anatomy compatible with a proximal optimization technique
- •Post main branch treatment (stenting then POT): Absence of side branch occlusion Or low flow associated with ongoing ischemia (either chest pain or ST changes)
- •Male or female patient >18 years old
排除标准
- •Acute myocardial infarction with ongoing ST-elevation
- •Cardiogenic shock
- •Requirement for ongoing hemodialysis
- •Life-expectancy limited to <12 months due to co-morbid condition
- •Lesion involves the left main coronary artery
- •Lesion requiring a double stenting
- •Plan to treat >1 other coronary vessel at the time of the index procedure
- •Two lesions treated in the same session: unsuccessful PCI on the single non bifurcation lesion in a non-target vessel before the treatment of the target lesion.
- •Chronic total occlusion of any target vessel
- •Left ventricular ejection fraction <20%
- •Side branch TIMI Flow <3
- •Pre-dilatation of the Side Branch during the procedure prior to randomization
- •Known allergy to Aspirin
- •Known allergy to Clopidorel and Prasugrel and Ticagrelor
- •Known allergy to stent drug elutant
- •Known allergy to any other component of Onyx Resolute stent
- •Ongoing participation in another investigational device or drug study
- •Inability to provide informed consent
- •Patients under judicial protection, tutorship or curatorship
- •Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures
结局指标
主要结局
Periprocedural Myocardial infarction
时间窗: up to 48 hours post-procedure, up to 12 months
Rate of peri-procedural Myocardial Infarction (MI) at discharge or 48 hours post-procedure whichever comes first as judged by clinical evaluation in association with day-1 troponin evaluation using the ARC-2 definition
次要结局
- Angina status(1 month and 12 months)
- Technical success (2)(Intraoperative, up to 12 months)
- Target Lesion Revascularization (TLR)(1 month and 12 months)
- Technical success (3)(up to 12 months)
- Technical success (4)(Intraoperative, up to 12 months)
- Technical success (5)(Intraoperative, up to 12 months)
- Target Lesion Failure (TLF)(1 month and 12 months)
- Technical success (1)(Intraoperative, up to 12 months)
- Stent thrombosis:(1 month and 12 months)
- Technical success (6)(Intraoperative, up to 12 months)