NCT04077762 Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
| NCT ID | NCT04077762 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Minneapolis Heart Institute Foundation |
| Condition | Patient Satisfaction |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,266 participants |
| Start Date | 2019-11-15 |
| Primary Completion | 2027-08-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,266 participants in total. It began in 2019-11-15 with a primary completion date of 2027-08-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Emmanouil Brilakis, MD, PhD
PRINCIPAL INVESTIGATOR
Minneapolis Heart Institute Foundation
Frequently Asked Questions
Who can join the NCT04077762 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patient Satisfaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04077762 currently recruiting?
Yes, NCT04077762 is actively recruiting participants. Contact the research team at bavana.rangan@allina.com for enrollment information.
Where is the NCT04077762 trial being conducted?
This trial is being conducted at San Francisco, United States, Jacksonville, United States, Decatur, United States, Detroit, United States and 2 additional locations.
Who is sponsoring the NCT04077762 clinical trial?
NCT04077762 is sponsored by Minneapolis Heart Institute Foundation. The principal investigator is Emmanouil Brilakis, MD, PhD at Minneapolis Heart Institute Foundation. The trial plans to enroll 3,266 participants.