Coronary OcclusionPOL-CTONCT07330622
Polish Registry of Percutaneous Coronary Intervention for Chronic Total Occlusions
An observational study of Coronary Occlusion and Percutaneous Coronary Intervention, run by National Institute of Cardiology, Warsaw, Poland at 21 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Occlusion, Percutaneous Coronary Intervention
- How many people
- 1,000 participants
- Where
- 21 sitesPoland
- Study dates
- 21 May 2025to Jun 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing CTO PCI at participating centers.
Who may be able to join
- Patients undergoing CTO PCI based on clinical grounds
Who cannot join
- Age <18 years
- Patient's refusal to participate in the registry
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Izabela Majewska contact
21 sites in 1 country
Poland21 sites, 21 recruiting
- Recruiting
Medical University of Białystok
Bialystok
Grzegorz Mężynski
- Recruiting
Szpital Zachodni
Grodzisk Mazowiecki
Piotr Pawluczuk
- Recruiting
Specialist Hospital in Inowrocław
Inowrocław
Marek Radomski
- Recruiting
Medical University of Silesia
Katowice
Paweł Gąsior
Mariusz Łebek
- Recruiting
Institute of Cardiology
Krakow
Leszek Bryniarski
- Recruiting
St. John Paul II Hospital
Krakow
Daniel Rzeźnik
Jacek Legutko
- Recruiting
Provincial Hospital in Łomża
Łomża
Grzegorz Horszczaruk
- Recruiting
Copper Health Centre Inc.
Lubin
Adrian Włodarczak
- Recruiting
1st Military Clinical Hospital
Lublin
Grzegorz Sobieszek
- Recruiting
Hospital of the Ministry of the Interior and Administration
Lublin
Jakub Drozd
- Recruiting
University of Applied Science in Nowy Sącz
Nowy Sącz
Aleksander Zeliaś
- Recruiting
Masovian Specialist Hospital
Ostrołęka
Paweł Radecki
- Recruiting
Poznań University of Medical Sciences
Poznan
Sylwia Iwańczyk
Wojciech Skorupski
- Recruiting
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Puławach
Puławy
Marek Jankiewicz
- Recruiting
Specialistic Hospital
Radom
Wojciech Dworzański
- Recruiting
The Ministry of Internal Affairs and Administration Hospital
Rzeszów
Piotr Wańczura
Wojciech Stećko
- Recruiting
The Doctor Sokolowski Hospital
Wałbrzych
Michał Kryjak
- Recruiting
Military Institute of Medicine - National Research Institute
Warsaw
Piotr Kwiatkowski
Michał Malinowski
- Recruiting
National Institute of Cardiology
Warsaw
Maksymilian Opolski
Hubert Borzuta
- Recruiting
Military Hospital in Wrocław
Wroclaw
Krzysztof Ściborski
- Recruiting
University Hospital in Wroclaw
Wroclaw
Wojciech Zimoch
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Keywords
- coronary artery disease, percutaneous coronary intervention, coronary chronic total occlusion
- Medical subject headings
- Coronary Occlusion, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Achievement of Thrombolysis In Myocardial Infarction grade 3 flow in all ≥2.5-mm distal branches with <30% residual stenosis.
Measured: procedural (1 day)
Secondary outcomes (10)
Total procedure time
Total procedure time in minutes.
Measured: procedural (1 day)
Fluoroscopy time
Fluoroscopy time in minutes.
Measured: procedural (1 day)
Radiation dose
Total radiation dose in Gy and uGycm2.
Measured: procedural (1 day)
Contrast volume
Total contrast volume in mL.
Measured: procedural (1 day)
Number and type of procedural complications
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).
Measured: procedural (1 day)
Successful guidewire crossing through CTO
Rate of successful guidewire crossing through CTO.
Measured: procedural (1 day)
Time of successful guidewire crossing
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.
Measured: procedural (1 day)
Target lesion failure
Total number of cardiac death, target vessel-related myocardial infarction or clinically-driven target lesion revascularization
Measured: in-hospital (2-5 days)
Target lesion failure
otal number of cardiac death, target vessel-related myocardial infarction or clinically-driven target lesion revascularization
Measured: 1 year
Death
Any death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start21 May 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Polish Cardiac Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330622
- Sponsor's protocol ID
- 4.49/III/24
- Acronym
- POL-CTO
- Status last verified
- Oct 2025
- First submitted
- 29 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polish Registry of Percutaneous Coronary Intervention for Chronic Total Occlusions (POL-CTO Registry)
- ClinicalTrials.gov ID
- NCT07330622
- Acronym / sponsor ID
- POL-CTO / 4.49/III/24
- Keywords
- coronary artery disease, percutaneous coronary intervention, coronary chronic total occlusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Polish Cardiac Society
- Study start
- 21 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing CTO PCI at participating centers.
Key inclusion criteria (1 listed)
- Patients undergoing CTO PCI based on clinical grounds
Key exclusion criteria (2 listed)
- Age <18 years
- Patient's refusal to participate in the registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
Total procedure time
Time frame: procedural (1 day)
Fluoroscopy time
Time frame: procedural (1 day)
Radiation dose
Time frame: procedural (1 day)
Contrast volume
Time frame: procedural (1 day)
Number and type of procedural complications
Time frame: procedural (1 day)
Successful guidewire crossing through CTO
Time frame: procedural (1 day)
Time of successful guidewire crossing
Time frame: procedural (1 day)
Target lesion failure
Time frame: in-hospital (2-5 days)
Target lesion failure
Time frame: 1 year
Death
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Izabela Majewska contact
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Occlusion and Percutaneous Coronary Intervention, run by National Institute of Cardiology, Warsaw, Poland at 21 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maksymilian Opolski, MD, PhD (0048223434127, mopolski@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: procedural (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.