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

NCT04077762 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3266

Last updated 2025-01-24

No results posted yet for this study

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

Interventions

PROCEDURE

Radial Access

Radial Access

PROCEDURE

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

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

PROCEDURE

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.

Sponsors & Collaborators

  • Minneapolis Heart Institute Foundation

    lead OTHER

Principal Investigators

  • Emmanouil Brilakis, MD, PhD · Minneapolis Heart Institute Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2027-08-19
Completion
2028-08-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04077762 on ClinicalTrials.gov