Antegrade Dissection and Re-entry Versus Retrograde Strategy in Chronic Total Occlusion Percutaneous Coronary Intervention

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
1st Military Clinical Hospital
NOT_YET_RECRUITING
Lublin
Hospital of the Ministry of the Interior and Administration
RECRUITING
Lublin
National Institute of Cardiology
RECRUITING
Warsaw
Contact Information
Primary
Katarzyna Istynowicz
kistynowicz@ikard.pl
0048223434268
Backup
Wioletta Antos
wantos@ikard.pl
0048223434268
Time Frame
Start Date: 2025-07-28
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 74
Treatments
Other: ADR strategy
Patients with either failed or unattempted primary antegrade wiring strategy will be evenly randomized (1:1 fashion) to either ADR or retrograde CTO crossing strategy. The ADR, as part of the antegrade approach, involves extraplaque crossing of the occluded coronary artery with subsequent reentry into the distal true lumen using dedicated reentry systems or knuckle wire techniques.
Other: Retrograde strategy
Patients with either failed or unattempted primary antegrade wiring strategy will be evenly randomized (1:1 fashion) to either ADR or retrograde CTO crossing strategy. The retrograde technique, planned as the comparator to the ADR strategy, relies on crossing the occluded coronary artery from the distal vessel (i.e. against the original direction of blood flow). Retrograde CTO crossing is attempted either with retrograde intraplaque wiring or more frequently using the retrograde dissection and reentry techniques.
Sponsors
Collaborators: Medical Research Agency, Poland
Leads: National Institute of Cardiology, Warsaw, Poland

This content was sourced from clinicaltrials.gov