Radial versus State-of-the-Art Femoral Access to Reduce Bleeding and Access Site Complications in Cardiac Catheterization

What this Trial Is About

This research evaluates and compares two methods of vascular access—radial access and state-of-the-art femoral access—in adults undergoing cardiac catheterization without ST-segment elevation acute myocardial infarction. The study is a phase IV, prospective, open-label, randomized-controlled trial designed to assess bleeding and access site complications in these patients. It aims to determine which access method may reduce vascular access complications and bleeding events following cardiac catheterization procedures. Participants are randomly assigned in equal groups to either radial access or femoral access. Those in the femoral access group undergo a further randomization to receive either an 18 gauge or 21 gauge needle. For patients assigned to the 21 gauge micropuncture needle, the wire is advanced under fluoroscopy to ensure safe placement. These procedures are performed during the cardiac catheterization, which may include diagnostic angiography or planned urgent or elective percutaneous coronary intervention (PCI). During the study, researchers will monitor participants for vascular access complications and bleeding events up to 30 days after the procedure. Evaluation includes tracking the incidence of bleeding and access site complications classified by bleeding academic research consortium (BARC) types 2, 3, or 5. Participants provide informed consent and are assessed for eligibility before enrollment. The study excludes patients with certain medical conditions or planned surgeries that could affect outcomes or safety during the follow-up period.

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