Status:
COMPLETED
Coronary CTO PCI Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire (Gladius First)
Lead Sponsor:
National Institute of Cardiology, Warsaw, Poland
Conditions:
Coronary Artery Disease
Coronary Occlusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Gladius First trial is designed as a single-centre, open, prospective, randomized clinical trial aimed to assess the efficiency and safety of coronary chronic total occlusion (CTO) percutaneous co...
Eligibility Criteria
Inclusion
- delivery of an informed consent and compliance with study protocol
- CTO of a major coronary artery with at least intermediate difficulty score (J-CTO ≥1) as assessed by invasive angiography
- referral to clinically indicated CTO PCI with intended primary antegrade wiring strategy
Exclusion
- in-stent CTO
- unstable angina and/or myocardial infarction
- prior myocardial infarction within 4 weeks before study enrolment
- CTO of a major coronary artery with an easy difficulty score (J-CTO 0) as assessed by invasive coronary angiography
- lack of valid antegrade wire escalation strategy as assessed by 2 independent CTO PCI operators
- chronic kidney disease (defined as eGFR ≤30 ml/min/m2)
- contraindication to antiplatelet therapy and/or heparin
- severe inflammatory disease
- positive pregnancy test or breast-feeding
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04691778
Start Date
January 1 2021
End Date
January 30 2024
Last Update
October 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institute of Cardiology
Warsaw, Poland, 04-628