Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI
ADRENALINE
1 other identifier
interventional
74
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Jul 2025
Typical duration for not_applicable coronary-artery-disease
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2025
CompletedFirst Posted
Study publicly available on registry
March 17, 2025
CompletedStudy Start
First participant enrolled
July 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
January 2, 2026
December 1, 2025
2.7 years
March 4, 2025
December 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total procedure time
Total procedure time in minutes.
procedural (1 day)
Successful guidewire crossing through CTO
Rate of successful guidewire crossing through CTO.
procedural (1 day)
Secondary Outcomes (27)
Technical success
procedural (1 day)
Time of successful guidewire crossing
procedural (1 day)
Fluoroscopy time
procedural (1 day)
Radiation dose
procedural (1 day)
Contrast volume
procedural (1 day)
- +22 more secondary outcomes
Study Arms (2)
ADR strategy
OTHERPatients 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.
Retrograde strategy
OTHERPatients 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.
Interventions
CTO recanalization using retrograde approach performed as primary or secondary CTO PCI strategy (i.e. in case of unattempted or failed antegrade wiring, respectively).
CTO recanalization using ADR performed as primary or secondary CTO PCI strategy (i.e. in case of unattempted or failed antegrade wiring, respectively).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \<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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
National Institute of Cardiology
Warsaw, Warsaw, Poland
1st Military Clinical Hospital
Lublin, Poland
Hospital of the Ministry of the Interior and Administration
Lublin, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maksymilian Opolski
National Institute of Cardiology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2025
First Posted
March 17, 2025
Study Start
July 28, 2025
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
January 2, 2026
Record last verified: 2025-12