Polish Registry of Percutaneous Coronary Intervention for Chronic Total Occlusions

NCT ID: NCT07330622

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-21

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Occlusion Percutaneous Coronary Intervention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing CTO PCI based on clinical grounds

Exclusion Criteria

* Age \<18 years
* Patient's refusal to participate in the registry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role lead

Polish Cardiac Society

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of Białystok

Bialystok, , Poland

Site Status RECRUITING

Szpital Zachodni

Grodzisk Mazowiecki, , Poland

Site Status RECRUITING

Specialist Hospital in Inowrocław

Inowrocław, , Poland

Site Status RECRUITING

Medical University of Silesia

Katowice, , Poland

Site Status RECRUITING

Institute of Cardiology

Krakow, , Poland

Site Status RECRUITING

St. John Paul II Hospital

Krakow, , Poland

Site Status RECRUITING

Copper Health Centre Inc.

Lubin, , Poland

Site Status RECRUITING

1st Military Clinical Hospital

Lublin, , Poland

Site Status RECRUITING

Hospital of the Ministry of the Interior and Administration

Lublin, , Poland

Site Status RECRUITING

University of Applied Science in Nowy Sącz

Nowy Sącz, , Poland

Site Status RECRUITING

Masovian Specialist Hospital

Ostrołęka, , Poland

Site Status RECRUITING

Poznań University of Medical Sciences

Poznan, , Poland

Site Status RECRUITING

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Puławach

Puławy, , Poland

Site Status RECRUITING

Specialistic Hospital

Radom, , Poland

Site Status RECRUITING

The Ministry of Internal Affairs and Administration Hospital

Rzeszów, , Poland

Site Status RECRUITING

Military Institute of Medicine - National Research Institute

Warsaw, , Poland

Site Status RECRUITING

National Institute of Cardiology

Warsaw, , Poland

Site Status RECRUITING

The Doctor Sokolowski Hospital

Wałbrzych, , Poland

Site Status RECRUITING

Military Hospital in Wrocław

Wroclaw, , Poland

Site Status RECRUITING

University Hospital in Wroclaw

Wroclaw, , Poland

Site Status RECRUITING

Provincial Hospital in Łomża

Łomża, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Maksymilian Opolski, MD, PhD

Role: CONTACT

0048223434127

Izabela Majewska

Role: CONTACT

Facility Contacts

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Grzegorz Mężynski

Role: primary

Piotr Pawluczuk

Role: primary

Marek Radomski

Role: primary

Paweł Gąsior

Role: primary

Mariusz Łebek

Role: backup

Leszek Bryniarski

Role: primary

Daniel Rzeźnik

Role: primary

Jacek Legutko

Role: backup

Adrian Włodarczak

Role: primary

Grzegorz Sobieszek

Role: primary

Jakub Drozd

Role: primary

Aleksander Zeliaś

Role: primary

Paweł Radecki

Role: primary

Sylwia Iwańczyk

Role: primary

Wojciech Skorupski

Role: backup

Marek Jankiewicz

Role: primary

Wojciech Dworzański

Role: primary

Piotr Wańczura

Role: primary

Wojciech Stećko

Role: backup

Piotr Kwiatkowski

Role: primary

Michał Malinowski

Role: backup

Maksymilian Opolski

Role: primary

Michał Kryjak

Role: primary

Krzysztof Ściborski

Role: primary

Wojciech Zimoch

Role: primary

Grzegorz Horszczaruk

Role: primary

Other Identifiers

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4.49/III/24

Identifier Type: -

Identifier Source: org_study_id

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