RecruitingNot ApplicableNCT04077762

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)

Sponsor

Minneapolis Heart Institute Foundation

Enrollment

3,266 participants

Start Date

Nov 15, 2019

Study Type

INTERVENTIONAL

Conditions

Patient Satisfaction Vascular Access Complication

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Radial Access, a procedure called State-of-the-art femoral access with 18 gauge needle, and others for people with patient satisfaction and vascular access complication. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERadial Access

Radial Access

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

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

PROCEDUREState-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.