Clinical Trial

Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)

Study acronym: REBIRTH
Recruiting
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2019-09-03; most recent amendment 2025-01-22.
Status change: Not Yet Recruiting → Recruiting 2019-12-20
Trial Details
NCT Number NCT04077762
Lead Sponsor Minneapolis Heart Institute Foundation
Conditions Patient Satisfaction, Vascular Access Complication
Enrollment 3,266 participants
Start Date 2019-11-15
Primary Completion 2027-08-19 (estimated)
Study Completion 2028-08-19 (estimated)
Updated on ClinicalTrials.gov 2025-01-24