NCT04077762

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,266 (estimated)
• Sponsor: Minneapolis Heart Institute Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patient Satisfaction
• Vascular Access Complication

Interventions

Type	Name	Description
PROCEDURE	Radial Access	Radial Access
PROCEDURE	State-of-the-art femoral access with 18 gauge needle	State-of-the-art femoral access with 18 gauge needle
PROCEDURE	State-of-the-art femoral access with 21 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.

Timeline

• Start date: 2019-11-15
• Primary completion: 2027-08-19
• Completion: 2028-08-19
• First posted: 2019-09-04
• Last updated: 2025-01-24

Locations

6 sites across 1 country: United States