Comparing two ways to open chronic total coronary artery blockages: antegrade dissection-and-reentry versus retrograde approach.
Antegrade Dissection and Re-entry Versus Retrograde Strategy in Chronic Total Occlusion Percutaneous Coronary Intervention
This test will compare whether the antegrade dissection-and-reentry or the retrograde approach works better and is safer for people with difficult chronic total coronary occlusions who need PCI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Cardiology, Warsaw, Poland Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Warsaw, Warsaw and 2 other locations) |
| Trial ID | NCT06878729 on ClinicalTrials.gov |
What this trial studies
ADRENALINE is a multicenter, randomized study enrolling patients with difficult chronic total coronary occlusions (J-CTO score ≥2) who are angiographically suitable for either approach. Patients who have failed or not attempted primary antegrade wiring are randomized 1:1 to receive antegrade dissection-and-reentry (ADR) or a retrograde crossing strategy, while those with successful antegrade wiring are followed in an observational arm. Pre- and postprocedure evaluation includes cardiac magnetic resonance imaging with late gadolinium enhancement, serial cardiac biomarkers, and health-status questionnaires, and outcomes include procedure time, guidewire crossing success, periprocedural complications, myocardial injury, and operator stress. Follow-up health status is reassessed at 3 months and CMR is repeated within five days after the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic or ischemia-driven native CTOs of at least J-CTO score ≥2 who are judged by two independent operators to be equally suitable for either ADR or retrograde PCI and who can undergo CMR and provide informed consent.
Not a fit: Patients with easy or intermediate CTOs (J-CTO <2), acute myocardial infarction, cardiogenic shock, contraindications to PCI or CMR, pregnancy, or limited life expectancy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify which crossing strategy shortens procedure time, lowers complications, and improves recovery for patients with difficult CTO undergoing PCI.
How similar studies have performed: Both ADR and retrograde CTO techniques are established in observational and registry data, but randomized head-to-head comparisons are limited, making this a relatively under-tested direct comparison.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or viability) * at least difficult native CTO lesion with J-CTO difficulty score ≥2 points on invasive angiography * angiographic suitability for both ADR and the retrograde strategy as assessed by 2 independent hybrid CTO PCI operators * informed consent for participation in the study Exclusion Criteria: * \<18 years of age * acute myocardial infarction * cardiogenic shock * severe valvular disease * estimated life expectancy \<1 year * contraindication to PCI * contrast allergy * positive pregnancy test or breast-feeding * native CTO lesion with easy or intermediate difficulty score on invasive angiography (J-CTO score \<2 points) * lack of angiographic equipoise between the ADR and the retrograde strategy as assessed by 2 independent hybrid CTO PCI operators
Where this trial is running
Warsaw, Warsaw and 2 other locations
- National Institute of Cardiology — Warsaw, Warsaw, Poland (Recruiting)
- 1st Military Clinical Hospital — Lublin, Poland (Recruiting)
- Hospital of the Ministry of the Interior and Administration — Lublin, Poland (Recruiting)
Study contacts
- Principal investigator: Maksymilian Opolski — National Institute of Cardiology
- Study coordinator: Katarzyna Istynowicz
- Email: kistynowicz@ikard.pl
- Phone: 0048223434268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.