Actively Recruiting
Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI
Led by National Institute of Cardiology, Warsaw, Poland · Updated on 2026-01-02
74
Participants Needed
3
Research Sites
165 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
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 coronary intervention (PCI) using antegrade dissection and re-entry (ADR) versus retrograde strategy. Beyond the patient-oriented outcomes, the influence of the studied CTO PCI strategies on the stress levels among interventional cardiologists will be explored. The main questions it aims to answer are as follows: * What is the difference between ADR versus retrograde strategy with regard to total procedure time, the rates of successful guidewire crossing and periprocedural complications as well as stress levels experienced by interventional cardiologists? * Is retrograde approach associated with higher rates of myocardial injury/infarction based on cardiac troponin/cardiac magnetic resonance (CMR) as compared with ADR? Participants will undergo pre- and postprocedural laboratory testing (cardiac troponin, CK-MB), CMR for late gadolinium enhancement and health status assessment. Subjects undergoing successful CTO PCI using antegrade wiring strategy will be included in the observational arm.
CONDITIONS
Official 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 as determined by local heart team (presence of angina, symptoms, documented ischemia or viability)
- Difficult native CTO lesion with J-CTO difficulty score 2 or higher on invasive angiography
- Angiographic suitability for both ADR and retrograde strategies, confirmed by 2 independent CTO PCI operators
- Signed informed consent for study participation
You will not qualify if you...
- Age under 18 years
- Acute myocardial infarction
- Cardiogenic shock
- Severe valvular disease
- Estimated life expectancy less than 1 year
- Contraindication to PCI
- Allergy to contrast agents
- Positive pregnancy test or breastfeeding
- Native CTO lesion with easy or intermediate difficulty score (J-CTO score below 2)
- Lack of angiographic equipoise for ADR and retrograde strategies as assessed by 2 independent CTO PCI operators
AI-Screening
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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
CONTACT
W
Wioletta Antos
CONTACT
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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