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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinneapolis Heart Institute Foundation

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Radial Access
  • State-of-the-art femoral access with 18 gauge needle
  • State-of-the-art femoral access with 21 gauge needle

Treatment groups

3,266 Participants
are divided into 2 treatment groups