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Polish Registry of Percutaneous Coronary Intervention for Chronic Total Occlusions

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07330622
Acronym
POL-CTO
Enrollment
1000
Registered
2026-01-09
Start date
2025-05-21
Completion date
2026-06-30
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Occlusion, Percutaneous Coronary Intervention

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Polish Cardiac Society
CollaboratorOTHER
National Institute of Cardiology, Warsaw, Poland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing CTO PCI based on clinical grounds

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Technical successprocedural (1 day)Achievement of Thrombolysis In Myocardial Infarction grade 3 flow in all ≥2.5-mm distal branches with \<30% residual stenosis.

Secondary

MeasureTime frameDescription
Fluoroscopy timeprocedural (1 day)Fluoroscopy time in minutes.
Radiation doseprocedural (1 day)Total radiation dose in Gy and uGycm2.
Contrast volumeprocedural (1 day)Total contrast volume in mL.
Number and type of procedural complicationsprocedural (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).
Total procedure timeprocedural (1 day)Total procedure time in minutes.
Time of successful guidewire crossingprocedural (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.
Target lesion failurein-hospital (2-5 days)Total number of cardiac death, target vessel-related myocardial infarction or clinically-driven target lesion revascularization
Death1 yearAny death
Successful guidewire crossing through CTOprocedural (1 day)Rate of successful guidewire crossing through CTO.

Countries

Poland

Contacts

Primary ContactMaksymilian Opolski, MD, PhD
mopolski@ikard.pl0048223434127
Backup ContactIzabela Majewska
imajewska@ikard.pl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026