Comparing Healing of BioFreedom Drug-Coated Stents and Xience Drug-Eluting Stents in Acute Coronary Syndrome Patients with High Bleeding Risk Using Advanced Imaging

What this Trial Is About

Researchers are evaluating the vascular healing and neointimal transformation after implantation of two types of coronary stents in patients with acute coronary syndrome ACS who also have a high risk of bleeding. The study compares the BioFreedom22 polymer-free drug-coated stent, designed to reduce inflammation and promote early healing, with the Xience drug-eluting stent system. The goal is to better understand the healing patterns and safety of these stents using advanced optical coherence tomography OCT imaging. Participants will be randomly assigned to receive either the BioFreedom22 drug-coated stent or the Xience drug-eluting stent during their percutaneous coronary intervention. The key focus is on the stents neointimal strut coverage and transformation one month after implantation. The study uses high-resolution OCT to assess these outcomes, providing detailed information on how each device performs in the early healing phase. During the study, patients will undergo OCT imaging at one month post-procedure to measure neointimal strut coverage, thickness, area, and volume. Researchers will also monitor the incidence of major adverse cardiac events, stent thrombosis, and bleeding events over a 12-month period. Participants will be followed closely to evaluate the safety and efficacy of the stents, with total involvement lasting at least one year after their procedure.

A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug-coated Stents and the Xience Drug-eluting Stent System in Patients With Acute Coronary Syndrome and High Bleeding Risk Using Optical Coherence Tomography