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

RecruitingNAAges 18 Years - anyAllMinneapolis Heart Institute Foundation
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ1.5 while treated with oral vitamin K antagonists (i.e. warfarin) Receipt of oral factor Xa or IIa inhibitors โ‰ค24 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
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What it tests

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

6 sites
San Francisco VA Medical Center
San Francisco, United States
Mayo Clinic Florida
Jacksonville, United States
Joseph Maxwell Cleland Atlanta VA Medical Center
Decatur, United States
Henry Ford Hospital
Detroit, United States
Minneapolis Heart Institute Foundation
Minneapolis, United States
Oklahoma Heart Hospital
Oklahoma City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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