Comparing two ways to open chronic total coronary artery blockages: antegrade dissection-and-reentry versus retrograde approach.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.