Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Institute of Cardiology, Warsaw, Poland
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
<18 years of age
acute myocardial infarction
cardiogenic shock
severe valvular disease
Trial design
Design model
Parallel
Treatments tested in this trial
CTO PCI using ADR strategy
Procedure/SurgeryCTO recanalization using ADR performed as primary or secondary CTO PCI strategy (i.e. in case of unattempted or failed antegrade wiring, respectively).
CTO PCI using retrograde strategy
Procedure/SurgeryCTO recanalization using retrograde approach performed as primary or secondary CTO PCI strategy (i.e. in case of unattempted or failed antegrade wiring, respectively).
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: ADR strategyOther 1 intervention
Group B: Retrograde strategyOther 1 intervention
Trial outcomes
Primary outcomes
1
Total procedure time
Total procedure time in minutes.
Time frame
procedural (1 day)2
Successful guidewire crossing through CTO
Rate of successful guidewire crossing through CTO.
Time frame
procedural (1 day)Secondary outcomes
1
Technical success
Achievement of Thrombolysis In Myocardial Infarction grade 3 flow in all ≥2.5-mm distal branches with \<30% residual stenosis.
Time frame
procedural (1 day)2
Time of successful guidewire crossing
Time of successful guidewire crossing through CTO in minutes defined as the time from starting ADR or the retrograde approach to the time of successful CTO recanalization using any technique.
Time frame
procedural (1 day)3
Fluoroscopy time
Fluoroscopy time in minutes.
Time frame
procedural (1 day)4
Radiation dose
Total radiation dose in Gy and mGycm2.
Time frame
procedural (1 day)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Institute of Cardiology, Warsaw, Poland
Lead sponsor
Medical Research Agency, Poland
Collaborator
Source ClinicalTrials.gov