跳至主要内容
临床试验/NCT06931574
NCT06931574招募中不适用

Comparison of Cardiovascular Outcomes of Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bifurcation Lesions

Istanbul Mehmet Akif Ersoy Educational and Training Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Primary endpoint (Target lesion failure)

研究概览

简要总结

The Crush technique for coronary bifurcation lesions has evolved significantly since its introduction to the literature by Colombo et al. in 2003, with several iterations, including double kissing balloon inflation. The main disadvantage of the historical Crush technique is the low success rate of the final kissing balloon inflation. An improvement came with the introduction of double kissing crush stenting aiming for the shorter protrusion and kissing balloon dilation performed before and after main branch stent implantation. The double kissing crush provides a significant reduction in major adverse cardiovascular events compared to Provisional stenting, Crush, and Culotte techniques. Recently, a novel modified mini-crush technique (controlled balloon-crush) has been introduced to the literature and is one of the most up-to-date crush techniques. The main advantage of this technique over the contemporary mini-crush technique is that the side branch can be easily rewired, and the 1:1 size non-compliant balloon can easily pass through the crushed stent structure in the ostial part of the side branch. The basic rationale of this is that the crushing of the side branch stent is done in a more controlled manner (by slowly deflation of the side branch stent balloon), and this causes less disruption of the stent cells. To date, no data compares the mid-term outcomes of double kissing crush and controlled balloon-crush stenting techniques in patients with complex coronary bifurcation lesions. Hence, this study aimed to determine the clinical results of double kissing crush and controlled balloon-crush techniques under mid-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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged >18
  • PCI with either DK-crush or Controlled balloon-crush
  • Complex coronary bifurcation lesion (Medina 0.1.1, Medina 1.1.1)

排除标准

  • Non-complex bifurcation anatomy
  • Bail-out 2-stent (reverse modified mini-crush)
  • ST-elevation myocardial infarction
  • Cardiogenic shock status
  • In-stent restenosis
  • A previous of coronary artery bypass grafting
  • Implantation of bare-metal stent
  • End-stage hepatic or renal disease
  • <1-year life expectancy

结局指标

主要结局

Primary endpoint (Target lesion failure)

时间窗: 36 months

Target lesion failure (%) is defined as the combination of cardiac death (%), target vessel myocardial infarction (%), or target lesion revascularization (%) rates.

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

Principal Investigator

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

研究点 (1)

Loading locations...

相似试验