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

Part of paid clinical trials in San Francisco, California.

Sponsor
Minneapolis Heart Institute Foundation
Study ID
NCT04077762
Status
Recruiting
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Conditions

  • Patient Satisfaction
  • Vascular Access Complication

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 15, 2019
Status verified
Jan 2025
Primary completion
Aug 19, 2027
Completion
Aug 19, 2028

Study Design

Enrollment
3,266 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: 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).

Primary Outcome Measure

Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5) [ Time Frame: Evaluations will occur up to 30 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical CenterSan FranciscoCalifornia94121
Jeffrey Zimmet, MD, PhD
[email protected]
415-221-4810
Kendrick Shunk, MD, PhD
Mayo Clinic FloridaJacksonvilleFlorida32224
Federico Simon
[email protected]
904-953-4205
Abdallah El Sabbagh, MD
Joseph Maxwell Cleland Atlanta VA Medical CenterDecaturGeorgia30033
Nikki Leslie, RN
[email protected]
404-321-6111
Kreton Mavromatis, MD
Henry Ford HospitalDetroitMichigan48202
Michelle Butcher, RN
[email protected]
313-916-7614
Khaldoon Alaswad, MD
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
Bavana Rangan, BDS, MPH, CCRP
[email protected]
612-863-3852
Oklahoma Heart HospitalOklahoma CityOklahoma73120
Julia Myers, RN
[email protected]
405-608-1284
Mazen Abu-Fadel, MD

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By research site
San Francisco VA Medical Center· San Francisco, CAMayo Clinic Florida· Jacksonville, FLJoseph Maxwell Cleland Atlanta VA Medical Center· Decatur, GAHenry Ford Hospital· Detroit, MIMinneapolis Heart Institute Foundation· Minneapolis, MNOklahoma Heart Hospital· Oklahoma City, OK

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