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

December 29, 2025 updated by: National Institute of Cardiology, Warsaw, Poland

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maksymilian Opolski, MD, PhD
  • Phone Number: 0048223434127
  • Email: mopolski@ikard.pl

Study Contact Backup

Study Locations

  • Poland
      • Bialystok, Poland
        • Recruiting
        • Medical University of Białystok
        • Contact:
          • Grzegorz Mężynski
      • Grodzisk Mazowiecki, Poland
        • Recruiting
        • Szpital Zachodni
        • Contact:
          • Piotr Pawluczuk
      • Inowrocław, Poland
        • Recruiting
        • Specialist Hospital in Inowrocław
        • Contact:
          • Marek Radomski
      • Katowice, Poland
        • Recruiting
        • Medical University of Silesia
        • Contact:
          • Paweł Gąsior
        • Contact:
          • Mariusz Łebek
      • Krakow, Poland
        • Recruiting
        • St. John Paul II Hospital
        • Contact:
          • Jacek Legutko
        • Contact:
          • Daniel Rzeźnik
      • Krakow, Poland
        • Recruiting
        • Institute of Cardiology
        • Contact:
          • Leszek Bryniarski
      • Lubin, Poland
        • Recruiting
        • Copper Health Centre Inc.
        • Contact:
          • Adrian Włodarczak
      • Lublin, Poland
        • Recruiting
        • Hospital of the Ministry of the Interior and Administration
        • Contact:
          • Jakub Drozd
      • Lublin, Poland
        • Recruiting
        • 1st Military Clinical Hospital
        • Contact:
          • Grzegorz Sobieszek
      • Nowy Sącz, Poland
        • Recruiting
        • University of Applied Science in Nowy Sącz
        • Contact:
          • Aleksander Zeliaś
      • Ostrołęka, Poland
        • Recruiting
        • Masovian Specialist Hospital
        • Contact:
          • Paweł Radecki
      • Poznan, Poland
        • Recruiting
        • Poznan University of Medical Sciences
        • Contact:
          • Sylwia Iwańczyk
        • Contact:
          • Wojciech Skorupski
      • Puławy, Poland
        • Recruiting
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej w Puławach
        • Contact:
          • Marek Jankiewicz
      • Radom, Poland
        • Recruiting
        • Specialistic Hospital
        • Contact:
          • Wojciech Dworzański
      • Rzeszów, Poland
        • Recruiting
        • The Ministry of Internal Affairs and Administration Hospital
        • Contact:
          • Wojciech Stećko
        • Contact:
          • Piotr Wańczura
      • Warsaw, Poland
        • Recruiting
        • National Institute of Cardiology
        • Contact:
          • Maksymilian Opolski
        • Sub-Investigator:
          • Hubert Borzuta
        • Sub-Investigator:
          • Filip Kiljański
      • Warsaw, Poland
        • Recruiting
        • Military Institute of Medicine - National Research Institute
        • Contact:
          • Piotr Kwiatkowski
        • Contact:
          • Michał Malinowski
      • Wałbrzych, Poland
        • Recruiting
        • The Doctor Sokolowski Hospital
        • Contact:
          • Michał Kryjak
      • Wroclaw, Poland
        • Recruiting
        • Military Hospital in Wrocław
        • Contact:
          • Krzysztof Ściborski
      • Wroclaw, Poland
        • Recruiting
        • University Hospital in Wroclaw
        • Contact:
          • Wojciech Zimoch
      • Łomża, Poland
        • Recruiting
        • Provincial Hospital in Łomża
        • Contact:
          • Grzegorz Horszczaruk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients undergoing CTO PCI at participating centers.

Description

Inclusion Criteria:

  • Patients undergoing CTO PCI based on clinical grounds

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
procedural (1 day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total procedure time
Time Frame: procedural (1 day)
Total procedure time in minutes.
procedural (1 day)
Successful guidewire crossing through CTO
Time Frame: procedural (1 day)
Rate of successful guidewire crossing through CTO.
procedural (1 day)
Fluoroscopy time
Time Frame: procedural (1 day)
Fluoroscopy time in minutes.
procedural (1 day)
Contrast volume
Time Frame: procedural (1 day)
Total contrast volume in mL.
procedural (1 day)
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).
procedural (1 day)
Radiation dose
Time Frame: procedural (1 day)
Total radiation dose in Gy and uGycm2.
procedural (1 day)
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.
procedural (1 day)
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
in-hospital (2-5 days)
Target lesion failure
Time Frame: 1 year
otal number of cardiac death, target vessel-related myocardial infarction or clinically-driven target lesion revascularization
1 year
Death
Time Frame: 1 year
Any death
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cardiology, Warsaw, Poland

Collaborators

Polish Cardiac Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4.49/III/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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