Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
REBIRTH
1 other identifier
interventional
3,266
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
September 4, 2019
CompletedStudy Start
First participant enrolled
November 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 19, 2028
January 24, 2025
January 1, 2025
7.8 years
August 26, 2019
January 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)
Evaluations will occur up to 30 days
Secondary Outcomes (17)
Total number of BARC type 2, 3, or 5 bleeding events
Evaluations will occur up to 30 days
Number of Vascular access complications defined as the composite of arteriovenous fistula, arterial pseudoaneurysm, or arterial occlusion requiring intervention;
Evaluations will occur up to 30 days
Number of participants with Radial artery occlusion
Evaluations will occur up to 30 days
Number of participants with Access site crossover
Measured during procedure
Number of other vascular access related complications
Evaluations will occur up to 30 days
- +12 more secondary outcomes
Study Arms (2)
Radial access
ACTIVE COMPARATORRadial 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.
State-of-the-art femoral access
ACTIVE COMPARATORFemoral 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).
Interventions
State-of-the-art femoral access with 18 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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
San Francisco VA Medical Center
San Francisco, California, 94121, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Joseph Maxwell Cleland Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Related Publications (1)
Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
PMID: 34637140DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanouil Brilakis, MD, PhD
Minneapolis Heart Institute Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2019
First Posted
September 4, 2019
Study Start
November 15, 2019
Primary Completion (Estimated)
August 19, 2027
Study Completion (Estimated)
August 19, 2028
Last Updated
January 24, 2025
Record last verified: 2025-01