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临床试验/NCT06546748
NCT06546748已完成不适用

Mini Crush or Double Kissing Crush Stenting Techniques for Complex Left Main Bifurcation Lesions: the EVOLUTE-CRUSH Left Main Study

Istanbul Mehmet Akif Ersoy Educational and Training Hospital1 个研究点 分布在 1 个国家目标入组 531 人开始时间: 2024年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
531
试验地点
1
主要终点
Major cardiovascular events (MACE)

研究概览

简要总结

The Crush technique has evolved significantly since its introduction to the literature by Colombo et al in 2003, with multiple iterations including mini-crush (MC) and double kissing-crush (DKC) stenting techniques. The main principle of crush techniques for complex bifurcation lesions is to protrude the side branch (SB) stent towards the main branch to adequately cover the SB ostium and minimize the risk of SB ostium restenosis. It was noticed that the 4-5 mm protrusion of the SB stent resulted in a large volume of the crushed stent and the technique was modified into MC which aimed for approximately 1-2 mm protrusion by Galassi et al in 2007. Despite all the disadvantages of the crush technique, the final kissing balloon inflation (KBI) rate of this technique, along with several iterations has been up to 98%. Moreover, a recent meta-analysis showed that MC was associated with a reduction in risk of major cardiovascular events compared to provisional stenting, crush, and culotte techniques. The DKC is a planned 2-stent technique introduced by Chen et al. The ultimate innovation of this approach is that it is designed to increase the success rate of the final KBI. Provided recrossing of the crushed stent occurs through the proximal cell: another advantage of the DKC technique is to improve the success of KBI. The DKC significantly reduced major cardiovascular events (MACE) compared to provisional stenting, crush, TAP, and culotte. Until now, no clinical investigation has compared the DKC and MC in patients with complex left main bifurcation lesions. Therefore, this study sought to determine the clinical results of DKC and MC stenting techniques under long-term follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • true complex left main bifurcation lesions
  • stenting with double kissing-crush or mini-crush as a 2-stent strategy
  • participation in regular clinical follow-up

排除标准

  • prior history of coronary artery bypass grafting
  • cardiogenic shock
  • end-stage liver or kidney disease
  • allergy to antiplatelet therapy or contrast media
  • inappropriate dual antiplatelet therapy
  • critically ill with < 1-year life expectancy
  • absence of all medical records
  • PCI for ST-segment elevation myocardial infarction or in-stent restenosis
  • non-complex bifurcation lesions
  • treated with a bare metal stent

结局指标

主要结局

Major cardiovascular events (MACE)

时间窗: 12 months

Cardiac death, clinically-driven target lesion revascularization, target vessel myocardial infarction

次要结局

未报告次要终点

研究者

发起方
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ahmet Guner

Associate Professor of Cardiology

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

研究点 (1)

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