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

Launched by MINNEAPOLIS HEART INSTITUTE FOUNDATION · Sep 3, 2019

Keywords

ClinConnect Summary

The REBIRTH trial is studying two different ways to access blood vessels during a procedure called cardiac catheterization, which helps doctors diagnose and treat heart issues. Specifically, it compares the radial access (using the wrist) to the traditional femoral access (using the groin) to see which method leads to fewer complications like bleeding or problems at the access site. The trial is open to adults 18 years and older who are having this procedure for heart-related symptoms and who can safely undergo either access method.

Participants in this trial will be randomly assigned to one of the two groups: radial access or femoral access. If you're eligible, you'll need to give your consent to be part of the study. The trial is currently recruiting, so if you or a loved one are considering cardiac catheterization and meet the eligibility criteria, you may want to discuss this option with your healthcare provider. Remember, participation in the trial can help improve future care for patients undergoing similar procedures.

Gender

ALL

Eligibility criteria

• 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