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Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
Sponsor: Minneapolis Heart Institute Foundation
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 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.
Official title: Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access SIte Complication Reduction in Cardiac Catheterization (REBIRTH)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3266
Start Date
2019-11-15
Completion Date
2028-08-19
Last Updated
2025-01-24
Healthy Volunteers
No
Interventions
Radial Access
Radial Access
State-of-the-art femoral access with 18 gauge needle
State-of-the-art femoral access with 18 gauge needle
State-of-the-art femoral access with 21 gauge needle
State-of-the-art femoral access with 21 gauge needle. For patients randomized to micropuncture (21G) the micropuncture wire must be advanced under fluoroscopy to avoid inadvertent wiring of side-branches.
Locations (6)
San Francisco VA Medical Center
San Francisco, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Joseph Maxwell Cleland Atlanta VA Medical Center
Decatur, Georgia, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States