临床试验/CTRI/2024/09/073616

CTRI/2024/09/073616招募中不适用

Impact of Kissing balloon inflation on provisional Left Main Percutaneous Coronary Intervention: A Prospective Multicenter Randomized Trial(IKISS-LM Trial)

Principal Investigator6 个研究点分布在 1 个国家目标入组 630 人开始时间: 2024年9月24日最近更新: 2026年3月28日

试验速览

阶段: 不适用
状态: 招募中
发起方: Principal Investigator
入组人数: 630
试验地点: 6
主要终点: Primary endpoint of the study will be angiographically significant stenosis (greater than 50 percent stenosis by visual estimation) at the end of one year.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

With the advent of newer generation drug eluting stents (DES) and the subsequent reduction in restenosis rates, stenting of left main (LM) for distal bifurcation lesions has become a potential alternative to coronary artery bypass graft surgery (CABG).

研究设计

研究类型: Interventional
分配方式: Other

入排标准

年龄范围: 18.00 Year(s) 至 90.00 Year(s)（—）
性别: All

入选标准

•Non-complex distal LM bifurcation disease requiring percutaneous coronary intervention.
•Unprotected left main
•Patient â‰¥18 years old and willing to participate in the trial.

排除标准

•Complex LM bifurcation disease requiring upfront two-stent strategy.
•Patients previously underwent CABG
•Patients who underwent previously stenting to LM to LAD or LCX
•Allergic to antiplatelets (Aspirin, Clopidogrel, Ticagrelor, Prasugrel) or unable to use dual antiplatelet therapy (DAPT)
•Life expectancy less than 1 year
•Patient unable to give informed consent
•Women of child-bearing potential or lactating.

结局指标

主要结局

Primary endpoint of the study will be angiographically significant stenosis (greater than 50 percent stenosis by visual estimation) at the end of one year.

时间窗: At the end of one year.

次要结局

A composite of cardiac death, non-fatal myocardial infarction or target vessel failure at the end of 1 year. Other secondary end points include target vessel failure, stent thrombosis.(1 year)

研究者

发起方

Principal Investigator

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Dr Ankush Gupta

Army Institute of Cardio Thoracic Sciences

研究点 (6)

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