跳至主要内容
临床试验/NCT06880978
NCT06880978招募中不适用

Mini-Crush or Controlled Balloon-Crush for True 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 400 人开始时间: 2025年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Major adverse cardiac events (MACE)

研究概览

简要总结

The mini-crush technique is one of the leading 2-stent techniques frequently applied by interventional cardiologists to treat complex bifurcation lesions. In the last 20 years, many technical innovations and iterations of mini-crush technique have been developed, and it maintains its popularity among invasive cardiologists. Moreover, mini-crush and double kissing-crush techniques have been compared in terms of clinical results in both left main and non-left main coronary bifurcation patient populations and no significant difference was found. However, the most important challenges of the mini-crush technique are the rewiring and advancement of a 1:1 non-compliant side-branch balloon after the main branch stent has been implanted. These challenges usually necessitate the use of a low profile balloon or additional support maneuvers (such as anchor balloon). Recently, a novel modified mini-crush-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. This prospective observational study aims to assess the procedural and 1-year clinical outcomes of the contemporary mini-crush and controlled balloon-crush (modified mini-crush) double stenting techniques in patients with true coronary bifurcation lesions.

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

  • •Aged >18
  • •PCI with mini-crush or controlled balloon-crush
  • •Complex coronary bifurcation lesion (Medina 0.1.1 and Medina 1.1.1)

排除标准

  • •Non-complex bifurcation anatomy
  • •Bail-out 2-stent (reverse mini-crush or reverse controlled balloon-crush)
  • •ST-elevation myocardial infarction
  • •Cardiogenic shock status
  • •In-stent restenosis
  • •A history 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

Major adverse cardiac events (MACE)

时间窗: 12-months

The primary endpoint is defined as the composite of the rates of major adverse cardiac events (MACE) (%) including cardiac death (%), target vessel myocardial infarction (%), and target lesion revascularization (%).

次要结局

  • Major adverse cardiovascular and cerebral events (MACCE)(12-months)

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)

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