Comparing Drug-Coated Balloon Treatment to Standard Medical Care for High-Risk Lipid-Rich Coronary Plaques in Adults with Acute Coronary Syndrome

What this Trial Is About

This trial investigates whether treating vulnerable plaques in the coronary arteries with a drug-coated balloon can reduce their risk compared to standard medication alone in adults with acute coronary syndrome ACS. The study focuses on plaques with high fat content that may cause future heart problems. Researchers aim to find out if this treatment lowers the fat inside plaques more than medication and if it is safe. Participants are randomly assigned to one of two groups one receives a paclitaxel-coated drug-eluting balloon treatment along with guideline-directed medical therapy, while the other group receives only the medical therapy. The balloon is sized and inflated in the affected artery segment during a planned heart procedure PCI. The study includes imaging with near-infrared spectroscopy intravascular ultrasound NIRS-IVUS and computed tomography coronary angiography CCTA to assess plaque characteristics. Participants will undergo coronary artery imaging during their PCI, a heart CT scan within 2 weeks and again at about 9 months, and a follow-up heart catheterization 9 months later to check plaque changes. Researchers will measure changes in plaque fat content maxLCBI4mm, safety events, and other imaging parameters. The study follows participants for up to 5 years to monitor clinical outcomes and safety.

Drug-Eluting Balloon Treatment vs. Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques