Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI

Condition(s) studied

Investigational drug(s) / intervention(s)

CTO PCI using ADR strategy: CTO 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: CTO recanalization using retrograde approach performed as primary or secondary CTO PCI strategy (i.e. in case of unattempted or failed antegrade wiring, respectively).

Study 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

Primary outcome measure(s)

• Total procedure time — procedural (1 day)
  Total procedure time in minutes.
• Successful guidewire crossing through CTO — procedural (1 day)
  Rate of successful guidewire crossing through CTO.

Trial sites (3)

More National Institute of Cardiology, Warsaw, Poland trials in Poland

Other trials for the same condition