跳至主要内容
临床试验/NCT05100992
NCT05100992招募中不适用

Prospective Global Registry of Percutaneous Coronary Intervention in Bifurcation Lesions (PROGRESS-BIFURCATION)

Minneapolis Heart Institute Foundation2 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2020年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
4,000
试验地点
2
主要终点
Procedural Success During Bifurcation PCI

研究概览

简要总结

Coronary bifurcation lesions are lesions (or blockages) that occur at or near the intersection of a major coronary artery and one of the arteries' side branches.

Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized, and the procedural outcomes.

详细描述

Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. Several techniques are currently being utilized to treat coronary bifurcation lesions, including a 1-stent provisional stenting technique. Various 2-stent techniques are also performed, including: double kiss crush (DK crush4), culotte, T and protrusion (TAP), crush, mini-crush, reverse crush and V-stenting. The optimal technique for bifurcation stenting when two stents are required remains controversial; however, the DK crush technique appears to have stronger data, especially for left main bifurcations. However, DK crush can be challenging to perform, requiring several steps and frequent troubleshooting.

The adoption of DK crush and other 2-stent bifurcation strategies, as well as the rigor of implementation, have received limited study. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized,

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

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

  • Over 18 years of age
  • undergoing bifurcation percutaneous coronary intervention

排除标准

  • 未提供

结局指标

主要结局

Procedural Success During Bifurcation PCI

时间窗: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.

procedural success is defined as the absence of in-hospital major cardiac adverse events (MACE), including any of the following adverse events prior to hospital discharge: death, stroke, myocardial infarction, recurrent angina requiring urgent repeat target vessel revascularization with PCI or coronary bypass surgery, and tamponade requiring pericardiocentesis or surgery.

次要结局

  • Technical Success(From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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