Polish Registry of Percutaneous Coronary Intervention for Chronic Total Occlusions

NCT07330622 | Recruiting DMC

• 1 other identifier: 4.49/III/24
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Coronary Occlusion; Percutaneous Coronary Intervention

Keywords

coronary artery disease; percutaneous coronary intervention; coronary chronic total occlusion

Outcome Measures

Primary Outcomes (1)

• Technical success

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

  procedural (1 day)

Secondary Outcomes (10)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing CTO PCI at participating centers.

You may qualify if:

• Patients undergoing CTO PCI based on clinical grounds

You may not qualify if:

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

Sponsors & Collaborators

• Polish Cardiac Society: collaborator
• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (21)

Medical University of Białystok

Bialystok, Poland

RECRUITING

Szpital Zachodni

Grodzisk Mazowiecki, Poland

RECRUITING

Specialist Hospital in Inowrocław

Inowrocław, Poland

RECRUITING

Medical University of Silesia

Katowice, Poland

RECRUITING

Institute of Cardiology

Krakow, Poland

RECRUITING

St. John Paul II Hospital

Krakow, Poland

RECRUITING

Copper Health Centre Inc.

Lubin, Poland

RECRUITING

1st Military Clinical Hospital

Lublin, Poland

RECRUITING

Hospital of the Ministry of the Interior and Administration

Lublin, Poland

RECRUITING

University of Applied Science in Nowy Sącz

Nowy Sącz, Poland

RECRUITING

Masovian Specialist Hospital

Ostrołęka, Poland

RECRUITING

Poznań University of Medical Sciences

Poznan, Poland

RECRUITING

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Puławach

Puławy, Poland

RECRUITING

Specialistic Hospital

Radom, Poland

RECRUITING

The Ministry of Internal Affairs and Administration Hospital

Rzeszów, Poland

RECRUITING

Military Institute of Medicine - National Research Institute

Warsaw, Poland

RECRUITING

National Institute of Cardiology

Warsaw, Poland

RECRUITING

The Doctor Sokolowski Hospital

Wałbrzych, Poland

RECRUITING

Military Hospital in Wrocław

Wroclaw, Poland

RECRUITING

University Hospital in Wroclaw

Wroclaw, Poland

RECRUITING

Provincial Hospital in Łomża

Łomża, Poland

RECRUITING

MeSH Terms

Conditions

Coronary Occlusion; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Maksymilian Opolski, MD, PhD

CONTACT

0048223434127; mopolski@ikard.pl

Izabela Majewska

CONTACT

imajewska@ikard.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: May 21, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-10

Locations

PL (21)