NCT04077762: REBIRTH

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

Recruiting now NA Last updated 24 January 2025

What this trial tests

NA trial testing Radial Access in Patient Satisfaction in 3,266 participants. Currently enrolling.

Timeline

15 November 2019

Primary endpoint
19 August 2027

19 August 2028

Quick facts

Lead sponsor	Minneapolis Heart Institute Foundation
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	3,266
Start date	15 November 2019
Primary completion	19 August 2027
Estimated completion	19 August 2028
Sites	6 locations across United States

Drugs / interventions tested

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

Conditions studied

• Patient Satisfaction — all drugs for Patient Satisfaction →
• Vascular Access Complication — all drugs for Vascular Access Complication →

Sponsor

Minneapolis Heart Institute Foundation

Who can join

18 and older, any sex, with Patient Satisfaction or Vascular Access Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ultrasound guidance for arterial (other than femoral) catheterisation in adults.
   Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, et al · · 2021 · cited 11× · PMID 34637140 · DOI 10.1002/14651858.cd013585.pub2
2. Ultrasound-Guided Femoral Vascular Access for Percutaneous Coronary and Structural Interventions.
   Xenogiannis I, Varlamos C, Keeble TR, Kalogeropoulos AS, et al · · 2023 · cited 6× · PMID 37370923 · DOI 10.3390/diagnostics13122028