Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06878729

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Post-procedural In-hospital Monitoring

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)

Follow-up

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

Loading map...

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

Similar Trials

24 Versus 12-Month Dual Antiplatelet Therapy After Drug-Elut...

Elevated Lipoprotein(a) Level

Actively Recruiting

1 location

A 10-Minute Cardiovascular Magnetic Resonance Protocol for C...

Coronary Artery Disease

Actively Recruiting

1 location

A Longitudinal Cohort of Patients With Acute Coronary Syndro...

Acute Coronary Syndrome

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here