Recruiting

Radial vs. Femoral

Sponsor:

Minneapolis Heart Institute Foundation

Code:

NCT04077762

Conditions

Patient Satisfaction

Vascular Access Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radial Access

State-of-the-art femoral access with 18 gauge needle

State-of-the-art femoral access with 21 gauge needle

Study Details

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.

Conditions

Patient Satisfaction

Vascular Access Complication

Study ID

NCT04077762

Start date

Nov 15, 2019

Status verified date

Aug, 2026

Completion date

Aug 19, 2028

Anticipated

Primary completion date

Aug 19, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3266 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

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.

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 and Locations

Central contacts

Bavana Rangan, BDS, MPH, CCRP

612-863-3852bavana.rangan@allina.com

Olga Mastrodemos

olga.mastrodemos@allina.com

Locations

San Francisco VA Medical Center

Recruiting

San Francisco, California, United States, 94121

Contacts

Jeffrey Zimmet, MD, PhD

415-221-4810jeffrey.zimmet@va.gov

Principal Investigator:

Kendrick Shunk, MD, PhD

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Federico Simon

904-953-4205Simon.FedericoRey@mayo.edu

Principal Investigator:

Abdallah El Sabbagh, MD

Joseph Maxwell Cleland Atlanta VA Medical Center

Recruiting

Decatur, Georgia, United States, 30033

Contacts

Nikki Leslie, RN

404-321-6111nikki.leslie@va.gov

Principal Investigator:

Kreton Mavromatis, MD

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Bavana Rangan, BDS, MPH, CCRP

612-863-3852bavana.rangan@allina.com

Oklahoma Heart Hospital

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Rebecca Straily, RN

405-608-1287rstraily@okheart.com

Principal Investigator:

Mazen Abu-Fadel, MD

More Information

Sponsor

Minneapolis Heart Institute Foundation

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Heart Institute Foundation on 2026-08-19.