跳至主要内容
临床试验/NCT05977842
NCT05977842已完成不适用

Drug-coated Balloon in de Novo Chronic Total Occlusions (CTO-DENOVO Registry)

National Institute of Cardiology, Warsaw, Poland33 个研究点 分布在 12 个国家目标入组 309 人开始时间: 2012年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
309
试验地点
33
主要终点
Target lesion failure

研究概览

简要总结

The CTO-DENOVO study is a multicenter registry of consecutive patients with de novo coronary chronic total occlusions (CTO) undergoing successful CTO recanalization with the use of drug-coated balloon (DCB)-only strategy. The primary endpoint is target lesion failure at 6 months. The secondary endpoints are: 1) late lumen loss on follow-up angiography, and 2) minimal lumen area on follow-up intravascular ultrasound.

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

  • de novo coronary CTO undergoing successful recanalization with the use of DCB-only strategy at the occlusion site

排除标准

  • de novo coronary CTO undergoing successful recanalization with the use of DES at the occlusion site
  • in-stent CTO

结局指标

主要结局

Target lesion failure

时间窗: 6 months

Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization

次要结局

  • Late lumen loss(3 months)
  • Minimal lumen area(3 months)

研究者

发起方
National Institute of Cardiology, Warsaw, Poland
申办方类型
Other
责任方
Sponsor

研究点 (33)

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