NCT06878729 Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI
| NCT ID | NCT06878729 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Cardiology, Warsaw, Poland |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2025-07-28 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 74 participants in total. It began in 2025-07-28 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Maksymilian Opolski
PRINCIPAL INVESTIGATOR
National Institute of Cardiology
Frequently Asked Questions
Who can join the NCT06878729 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06878729 currently recruiting?
Yes, NCT06878729 is actively recruiting participants. Contact the research team at kistynowicz@ikard.pl for enrollment information.
Where is the NCT06878729 trial being conducted?
This trial is being conducted at Warsaw, Poland, Lublin, Poland, Lublin, Poland.
Who is sponsoring the NCT06878729 clinical trial?
NCT06878729 is sponsored by National Institute of Cardiology, Warsaw, Poland. The principal investigator is Maksymilian Opolski at National Institute of Cardiology. The trial plans to enroll 74 participants.