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NCT Number: NCT07330622

Polish Registry of Percutaneous Coronary Intervention for Chronic Total Occlusions

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Białystok, Bialystok, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing CTO PCI based on clinical grounds

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Technical success

    Time frame: procedural (1 day)

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

Secondary outcomes

  1. Total procedure time

    Time frame: procedural (1 day)

    Total procedure time in minutes.

  2. Fluoroscopy time

    Time frame: procedural (1 day)

    Fluoroscopy time in minutes.

  3. Radiation dose

    Time frame: procedural (1 day)

    Total radiation dose in Gy and uGycm2.

  4. Contrast volume

    Time frame: procedural (1 day)

    Total contrast volume in mL.

  5. Number and type of procedural complications

    Time frame: procedural (1 day)

    Total number and specification of procedural complications (death, non-fatal myocardial infarction, cardiac tamponade requiring pericardiocentesis, coronary perforation, stroke, major bleeding according to Bleeding Academic Research Consortium).

  6. Successful guidewire crossing through CTO

    Time frame: procedural (1 day)

    Rate of successful guidewire crossing through CTO.

  7. Time of successful guidewire crossing

    Time frame: procedural (1 day)

    Time of successful guidewire crossing through CTO in minutes defined as the time from starting primary CTO PCI strategy to the time of successful CTO recanalization using any technique.

  8. Target lesion failure

    Time frame: in-hospital (2-5 days)

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

  9. Target lesion failure

    Time frame: 1 year

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

  10. Death

    Time frame: 1 year

    Any death

Study contacts

Contact information is provided by the study sponsor or research team.

Izabela Majewska

CONTACT

[email protected]

Maksymilian Opolski, MD, PhD

CONTACT

[email protected]

0048223434127

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Other

Collaborators

  • Polish Cardiac Society

Registry information

Official study title

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

Acronym: POL-CTO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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