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What this study is

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.

What's being tested

  • Radial Access

    Intervention · PROCEDURE

    Radial Access

  • State-of-the-art femoral access with 18 gauge needle

    Intervention · PROCEDURE

    State-of-the-art femoral access with 18 gauge needle

  • State-of-the-art femoral access with 21 gauge needle

    Intervention · PROCEDURE

    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.

Study details

Official title
Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access SIte Complication Reduction in Cardiac Catheterization (REBIRTH)
Sponsor
Minneapolis Heart Institute Foundation
Conditions
Patient Satisfaction · Vascular Access Complication
Enrolling
3,266 people
Starts
2019-11-15
Est. completion
2028-08-19
Design
Open-label, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗