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

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.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

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.

Locations (6)