Status:
RECRUITING
Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
Lead Sponsor:
Minneapolis Heart Institute Foundation
Conditions:
Patient Satisfaction
Vascular Access Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a phase IV, prospective, open label, randomized-controlled study that will compare radial access with state-of-the-art femoral access in patients without ST-segment elevation acute myocardial ...
Eligibility Criteria
Inclusion
- Age 18 years and older
- Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI
- Has provided informed consent and agrees to participate
- Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access
Exclusion
- Primary PCI for STEMI
- Planned right heart catheterization
- Valvular heart disease requiring valve surgery within 30 days after the index procedure
- Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access if a dialysis graft is present in one)
- Peripheral arterial disease prohibiting vascular access
- Presence of bilateral internal mammary artery coronary bypass grafts
- International normalized ratio ≥1.5 while treated with oral vitamin K antagonists (i.e. warfarin) Receipt of oral factor Xa or IIa inhibitors ≤24 h before procedure
- Planned staged PCI within 30 days after index procedure.
- Any planned surgeries within 30 days after index procedure
- Planned dual arterial access (for example for chronic total occlusion PCI)
- Coexisting conditions that limit life expectancy to less than 30 days
- Positive pregnancy test
Key Trial Info
Start Date :
November 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 19 2028
Estimated Enrollment :
3266 Patients enrolled
Trial Details
Trial ID
NCT04077762
Start Date
November 15 2019
End Date
August 19 2028
Last Update
January 24 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
San Francisco VA Medical Center
San Francisco, California, United States, 94121
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
3
Joseph Maxwell Cleland Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
4
Henry Ford Hospital
Detroit, Michigan, United States, 48202