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临床试验/NCT06284057
NCT06284057招募中不适用

Double Kissing (DK) vs Culotte Culotte. Lower Silesia Culotte Bifurcation Registry (LSCBR).

Regional Cardiology Center, The Copper Health Centre (MCZ),2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2013年4月1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
2
主要终点
Target lesion failure (TLF)

研究概览

简要总结

The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis.

详细描述

The study contains a retrospective analysis of subjects who have undergone PCI in two high-volume cooperative Cardiac Departments in the Lower Silesia Region (Poland) between April 2012 and January 2024. Data regarding all performed PCI from these periods were prescreened in terms of bifurcation lesion with subsequent implantation of two stents using the Culotte technique or the DK-Culotte technique. The indication for percutaneous coronary intervention (PCI) was based either on a judgment made by the Heart Team or on a particular clinical indication (ongoing ischemia, lack of will for the alternative treatment options, presence of significant angiographic CAD suitable for PCI due to ESC/ESH recommendation). The decision to perform the two-stent technique PCI was left to the operator's dissertation based on clinical and angiographical features. All patients were thoroughly informed about all therapeutic options and PCI-related risks before providing written informed consent for the procedure. There were no clinical or vessel-related exclusion criteria (lesion anatomy, length, tortuosity, severity). However, patients who had undergone PCI with coronary stents prior to the index procedure with respect to the bifurcation lesion studied were excluded from the study.

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

  • Presence of significant changes in the coronary bifurcation requiring the implantation of two coronary stents using the Culotte or DK Culotte technique.

排除标准

  • Patients who underwent PCI with coronary stents prior to the index procedure for the bifurcation lesion studied.

结局指标

主要结局

Target lesion failure (TLF)

时间窗: Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)

The primary endpoint was target lesion failure (TLF): the composite of cardiac death, target vessel myocardial infarction (TVMI), or clinically driven TLR.

次要结局

  • MACE(Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years))

研究者

发起方
Regional Cardiology Center, The Copper Health Centre (MCZ),
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrian Włodarczak

Professor

Regional Cardiology Center, The Copper Health Centre (MCZ),

研究点 (2)

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