Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
Recruiting now · Not applicable
Conditions studied: Patient Satisfaction, Vascular Access Complication
In brief
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.
Key facts
- Study ID
- NCT04077762
- Run by
- Minneapolis Heart Institute Foundation
- People needed
- 3266
- Starts
- 2019-11-15
- Expected to finish
- 2028-08-19
- Last updated by the study team
- 2025-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- San Francisco VA Medical Center — San Francisco, California, United States (enrolling)
- Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
- Joseph Maxwell Cleland Atlanta VA Medical Center — Decatur, Georgia, United States (enrolling)
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
- Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States (enrolling)
- Henry Ford Hospital — Detroit, Michigan, United States
Full record on ClinicalTrials.gov
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