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

Description

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.

Conditions

Patient Satisfaction, Vascular Access Complication

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Study Overview

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Study Details

Study overview

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.

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)

Condition
Patient Satisfaction
Intervention / Treatment

-

Contacts and Locations

San Francisco

San Francisco VA Medical Center, San Francisco, California, United States, 94121

Jacksonville

Mayo Clinic Florida, Jacksonville, Florida, United States, 32224

Decatur

Joseph Maxwell Cleland Atlanta VA Medical Center, Decatur, Georgia, United States, 30033

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Minneapolis

Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, United States, 55407

Oklahoma City

Oklahoma Heart Hospital, Oklahoma City, Oklahoma, United States, 73120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Minneapolis Heart Institute Foundation,

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

Study Record Dates

2028-08-19