Actively Recruiting
Antegrade Dissection and Re-entry Versus Retrograde Strategy in Chronic Total Occlusion Percutaneous Coronary Intervention
Led by National Institute of Cardiology, Warsaw, Poland · Updated on 2026-01-02
74
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
Sponsors
N
National Institute of Cardiology, Warsaw, Poland
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two approaches for coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI): antegrade dissection and re-entry (ADR) versus the retrograde strategy. The study aims to compare procedural outcomes such as total procedure time, success rates of guidewire crossing, procedural complications, and stress levels experienced by interventional cardiologists. It also examines whether the retrograde approach leads to higher rates of myocardial injury or infarction based on cardiac troponin levels and cardiac magnetic resonance (CMR). Participants with difficult CTO lesions will undergo pre-procedural assessments including cardiac magnetic resonance imaging, laboratory tests for cardiac markers, and health status questionnaires. Those with failed or unattempted primary antegrade wiring will be randomly assigned to either ADR or retrograde strategy groups. Patients with successful antegrade wiring will be followed in an observational arm. After the procedure, cardiac enzyme levels and CMR will be repeated, and health status reassessed three months later. The physical and mental stress of the cardiologists performing the procedures will also be monitored. Participants will be involved in laboratory testing before and after PCI, CMR scans within five days post-procedure, and health questionnaires at baseline and three months. Researchers will measure outcomes including procedure duration, guidewire crossing success, radiation exposure, contrast use, complications, myocardial injury and infarction, quality of life, and target lesion failure at three months. Stress indicators for physicians will be recorded during the procedure. The study lasts from procedure day through three months follow-up.
CONDITIONS
Brief Title
Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical indication for CTO PCI determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or viability)
- Difficult native CTO lesion with J-CTO difficulty score of 2 or higher on angiography
- Angiographic suitability for both ADR and retrograde strategy as assessed by 2 independent CTO PCI operators
- Provided informed consent for participation in the study
You will not qualify if you...
- Under 18 years of age
- Acute myocardial infarction
- Cardiogenic shock
- Severe valvular disease
- Estimated life expectancy less than 1 year
- Contraindication to PCI
- Allergy to contrast media
- Positive pregnancy test or currently breastfeeding
- Native CTO lesion with easy or intermediate difficulty score on angiography (J-CTO score less than 2)
- Lack of angiographic equipoise between ADR and retrograde strategy as assessed by 2 independent CTO PCI operators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo CTO PCI using either the ADR or retrograde strategy as randomized after the initial antegrade wiring attempt. The procedure involves recanalization of the occluded coronary artery using specialized techniques.
1 procedural visit (in-person)
Duration - Up to 5 days
Participants have cardiac biomarkers measured and cardiac magnetic resonance imaging performed within 5 days after the procedure to assess myocardial injury and infarction.
Approximately 2 visits (in-person)
Duration - 3 months
Participants have their health status reassessed at 3 months post-procedure to evaluate quality of life and clinical outcomes including any cardiac events.
1 follow-up visit (in-person)
Trial Site Locations
Total: 3 locations
1
National Institute of Cardiology
Warsaw, Warsaw, Poland
Actively Recruiting
2
1st Military Clinical Hospital
Lublin, Poland
Actively Recruiting
3
Hospital of the Ministry of the Interior and Administration
Lublin, Poland
Actively Recruiting
Research Team
K
Katarzyna Istynowicz
W
Wioletta Antos
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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