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临床试验/NCT07330622
NCT07330622招募中不适用

Polish Registry of Percutaneous Coronary Intervention for Chronic Total Occlusions (POL-CTO Registry)

National Institute of Cardiology, Warsaw, Poland21 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年5月21日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
21
主要终点
Technical success

研究概览

简要总结

The goal of this observational study is to evaluate the safety, efficacy, and clinical outcomes of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) in patients treated in contemporary clinical practice in Poland.

The main questions it aims to answer are:

  • What are the rates of procedural success and periprocedural complications of CTO PCI in routine clinical practice?
  • How do CTO PCI strategies and techniques, intravascular imaging, different treatment strategies, and mechanical circulatory support affect clinical outcomes?
  • How do clinical outcomes differ among different patient subgroups?
  • Can artificial intelligence-based analysis predict clinical and quality-of-life outcomes after CTO PCI?

Patients undergoing CTO PCI as part of their standard medical care will be prospectively enrolled in a national, multicenter registry, with clinical, procedural, and follow-up data collected to evaluate real-world outcomes.

详细描述

Coronary chronic total occlusions (CTO) are diagnosed in approximately 20% of patients undergoing invasive coronary angiography, and their presence is associated with significantly reduced quality of life and worse long-term prognosis compared with patients without a CTO. Successful CTO recanalization improves quality of life, regional and global left ventricular function, and reduces myocardial ischemia in most patients. Over the past decade, the success rate of percutaneous coronary intervention (PCI) for CTO has increased substantially, largely due to advances in dedicated equipment and specialized procedural techniques. Concurrently, there is a growing need to evaluate the safety and effectiveness of contemporary CTO PCI techniques in selected patient populations.

The aim of the POL-CTO registry is to expand current knowledge regarding the safety and efficacy of CTO PCI in the contemporary Polish population across a broad range of clinical scenarios. Specifically, the registry will examine the incidence and management of periprocedural complications, as well as the impact of post-procedural cardiac injury markers on clinical outcomes. Comparative analyses of PCI performed with versus without intravascular imaging, along with different treatment strategies (drug-coated balloon [DCB], drug-eluting stent [DES], or hybrid approaches), will be conducted. Additional objectives include evaluating the safety of PCI with mechanical circulatory support and predicting quality-of-life improvement using artificial intelligence-based analysis of baseline electrocardiograms. Finally, the study will focus on CTO PCI outcomes in high-risk subgroups, including patients with low ejection fraction, frailty syndrome, severe coronary calcification, diabetes, prior transcatheter aortic valve implantation, prior coronary artery bypass grafting, and in-stent CTO.

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

入选标准

  • Patients undergoing CTO PCI based on clinical grounds

排除标准

  • Age <18 years
  • Patient's refusal to participate in the registry

结局指标

主要结局

Technical success

时间窗: procedural (1 day)

Achievement of Thrombolysis In Myocardial Infarction grade 3 flow in all ≥2.5-mm distal branches with \<30% residual stenosis.

次要结局

  • Time of successful guidewire crossing(procedural (1 day))
  • Target lesion failure(1 year)
  • Death(1 year)
  • Total procedure time(procedural (1 day))
  • Fluoroscopy time(procedural (1 day))
  • Radiation dose(procedural (1 day))
  • Contrast volume(procedural (1 day))
  • Number and type of procedural complications(procedural (1 day))
  • Successful guidewire crossing through CTO(procedural (1 day))
  • Target lesion failure(in-hospital (2-5 days))

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 (21)

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