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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
San Francisco VA Medical Center
RECRUITING
San Francisco
Florida
Mayo Clinic Florida
RECRUITING
Jacksonville
Georgia
Joseph Maxwell Cleland Atlanta VA Medical Center
RECRUITING
Decatur
Michigan
Henry Ford Hospital
NOT_YET_RECRUITING
Detroit
Minnesota
Minneapolis Heart Institute Foundation
RECRUITING
Minneapolis
Oklahoma
Oklahoma Heart Hospital
RECRUITING
Oklahoma City
Contact Information
Primary
Bavana Rangan, BDS, MPH, CCRP
bavana.rangan@allina.com
612-863-3852
Backup
Olga Mastrodemos
olga.mastrodemos@allina.com
Time Frame
Start Date: 2019-11-15
Estimated Completion Date: 2028-08-19
Participants
Target number of participants: 3266
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Minneapolis Heart Institute Foundation

This content was sourced from clinicaltrials.gov