Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
Purpose
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
- Patient Satisfaction
- Vascular Access Complication
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Radial access |
Radial access for cardiac catheterization. Radial access will be performed using ultrasound guidance and a micropuncture needle or catheter-over-needle system, as per the local standard of care. |
|
|
Active Comparator State-of-the-art femoral access |
Femoral access for cardiac catheterization. Femoral access will be obtained using state-of-the-art techniques (ultrasound and fluoroscopic guidance for arterial puncture, immediate femoral angiography after obtaining access and use of a vascular closure device whenever possible). |
|
Recruiting Locations
San Francisco VA Medical Center
San Francisco, California 94121
San Francisco, California 94121
Mayo Clinic Florida
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Joseph Maxwell Cleland Atlanta VA Medical Center
Decatur, Georgia 30033
Decatur, Georgia 30033
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Oklahoma Heart Hospital
Oklahoma City, Oklahoma 73120
Oklahoma City, Oklahoma 73120
More Details
- Status
- Recruiting
- Sponsor
- Minneapolis Heart Institute Foundation