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REBIRTH Study: Comparing Access Methods for Cardiac Catheterization

This study, called REBIRTH, is looking at the best way to access your heart during a cardiac catheterization procedure. It compares two methods: Radial Access (through your wrist) and State-of-the-art femoral access (through your groin). The goal is to see which method leads to fewer bleeding issues and complications at the access site. You might be able to join if you are 18 or older, need a diagnostic angiography or planned PCI (percutaneous coronary intervention, a procedure to open blocked arteries), and can have either access method. Success in this study means a lower rate of bleeding and access site complications within 30 days. The study is currently recruiting a large number of participants.

Study design
This is a Phase 4, open-label, randomized study involving about 3266 participants. You would be randomly assigned to either radial access or state-of-the-art femoral access; those in the femoral access group would then be randomly assigned to use either an 18-gauge or 21-gauge needle.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be evaluated for up to 30 days after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04077762

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

Recruiting
NAAges 18+InterventionalTreatment
Minneapolis Heart Institute Foundation
~3,266 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Radial AccessState-of-the-art femoral access with 18 gauge needleState-of-the-art femoral access with 21 gauge needle

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)
Measured over Evaluations will occur up to 30 days

Conditions

Patient Satisfaction
Vascular Access Complication

Explore related trials

Ischemic Heart Disease

Where it's being run

6 sites across 6 states
California1
Florida1
Georgia1
Michigan1
Minnesota1
Oklahoma1

Study leadership

  • Emmanouil Brilakis, MD, PhD · PRINCIPAL_INVESTIGATOR · Minneapolis Heart Institute Foundation

Who to contact

Bavana Rangan, BDS, MPH, CCRP
[email protected]
612-863-3852
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)Evaluations will occur up to 30 days