Status:
RECRUITING
Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI
Lead Sponsor:
National Institute of Cardiology, Warsaw, Poland
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
Coronary Artery Disease
Coronary Occlusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The ADRENALINE trial has been designed as a multi-center, prospective randomized study to compare the procedural and periprocedural outcomes of coronary chronic total occlusion (CTO) percutaneous coro...
Detailed Description
The ADRENALINE trial is planned as a multicenter, prospective randomized research experiment in patients with clinical indication for PCI of CTO. The target population will comprise patients with at l...
Eligibility Criteria
Inclusion
- 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
- \<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
Key Trial Info
Start Date :
July 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06878729
Start Date
July 28 2025
End Date
September 30 2028
Last Update
January 2 2026
Active Locations (3)
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1
National Institute of Cardiology
Warsaw, Warsaw, Poland
2
1st Military Clinical Hospital
Lublin, Poland
3
Hospital of the Ministry of the Interior and Administration
Lublin, Poland