Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
NCT ID: NCT04077762
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3266 participants
INTERVENTIONAL
2019-11-15
2028-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radial access
Radial access for cardiac catheterization. Radial access will be performed using ultrasound guidance and a micropuncture needle or catheter-over-needle system, as per the local standard of care.
Radial Access
Radial Access
State-of-the-art femoral access
Femoral access for cardiac catheterization. Femoral access will be obtained using state-of-the-art techniques (ultrasound and fluoroscopic guidance for arterial puncture, immediate femoral angiography after obtaining access and use of a vascular closure device whenever possible).
State-of-the-art femoral access with 18 gauge needle
State-of-the-art femoral access with 18 gauge needle
State-of-the-art femoral access with 21 gauge needle
State-of-the-art femoral access with 21 gauge needle. For patients randomized to micropuncture (21G) the micropuncture wire must be advanced under fluoroscopy to avoid inadvertent wiring of side-branches.
Interventions
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Radial Access
Radial Access
State-of-the-art femoral access with 18 gauge needle
State-of-the-art femoral access with 18 gauge needle
State-of-the-art femoral access with 21 gauge needle
State-of-the-art femoral access with 21 gauge needle. For patients randomized to micropuncture (21G) the micropuncture wire must be advanced under fluoroscopy to avoid inadvertent wiring of side-branches.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Minneapolis Heart Institute Foundation
OTHER
Responsible Party
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Principal Investigators
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Emmanouil Brilakis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Minneapolis Heart Institute Foundation
Locations
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San Francisco VA Medical Center
San Francisco, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Joseph Maxwell Cleland Atlanta VA Medical Center
Decatur, Georgia, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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Kendrick Shunk, MD, PhD
Role: backup
Abdallah El Sabbagh, MD
Role: backup
Kreton Mavromatis, MD
Role: backup
Khaldoon Alaswad, MD
Role: backup
Mazen Abu-Fadel, MD
Role: backup
References
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Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
Other Identifiers
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REBIRTH
Identifier Type: -
Identifier Source: org_study_id
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