Actively Recruiting
Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
Led by Minneapolis Heart Institute Foundation · Updated on 2025-01-24
3266
Participants Needed
6
Research Sites
457 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 infarction undergoing cardiac catheterization. Subjects will be randomized 1:1 into 2 treatment groups: radial access and state-of-the-art femoral access. Randomization will be performed in blocks of 50 per site. Similarly, a second sub-randomization will be performed in the femoral access group into use of 18 vs 21 gauge needles, also in a 1:1 fashion.
CONDITIONS
Official Title
Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or planned urgent or elective PCI
- Has provided informed consent and agrees to participate
- Eligible to undergo cardiac catheterization via either radial or femoral access
You will not qualify if you...
- Primary PCI for STEMI
- Planned right heart catheterization
- Valvular heart disease requiring valve surgery within 30 days after the procedure
- Hemodialysis access in the arm to be used for PCI (opposite arm may be used for radial access)
- Peripheral arterial disease preventing vascular access
- Bilateral internal mammary artery coronary bypass grafts
- International normalized ratio 651.5 while on oral vitamin K antagonists
- Receipt of oral factor Xa or IIa inhibitors within 24 hours before procedure
- Planned staged PCI within 30 days after procedure
- Any planned surgeries within 30 days after procedure
- Planned dual arterial access
- Conditions limiting life expectancy to less than 30 days
- Positive pregnancy test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Actively Recruiting
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Joseph Maxwell Cleland Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Actively Recruiting
4
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Not Yet Recruiting
5
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
6
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
Research Team
B
Bavana Rangan, BDS, MPH, CCRP
CONTACT
O
Olga Mastrodemos
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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