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

Minneapolis Heart Institute Foundation

Status: Enrolling

Conditions: Vascular Access Complication; Patient Satisfaction

Treatments: Procedure: Radial Access; Procedure: State-of-the-art femoral access with 21 gauge needle; Procedure: State-of-the-art femoral access with 18 gauge needle

Study type: Interventional

Funder types: Other

Identifiers

NCT04077762

REBIRTH

Details and patient eligibility

About

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.

Enrollment: 3,266 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,266 participants in 2 patient groups

Radial access

Active Comparator group

Description:

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.

Treatment:

Procedure: Radial Access

State-of-the-art femoral access

Active Comparator group

Description:

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).

Treatment:

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

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