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NCT04077762NARecruiting

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

Minneapolis Heart Institute Foundation

Start Date

11/15/2019

Completion Date

8/19/2028

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Interventions

PROCEDURE

Radial Access

PROCEDURE

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

PROCEDURE

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

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Conditions

Patient SatisfactionVascular Access Complication

Locations

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