International Registry to Track Outcomes of Drug-Coated Balloon Use in Adults Undergoing PCI for New Coronary Artery Disease

What this Trial Is About

Researchers are conducting a prospective, international multi-center registry study to gather long-term clinical data on adult patients undergoing percutaneous coronary intervention PCI with drug-coated balloons DCB for new or untreated coronary artery disease. The study aims to evaluate how well drug-coated balloons perform in treating these heart artery conditions by tracking clinical outcomes over time. The registry collects data from multiple centers where clinical care and interventions such as the choice of drug-coated balloon, vessel preparation, and additional medications are decided by treating physicians based on standard care practices. No experimental treatments are assigned by the study. All participating sites submit their information into a centralized database managed by Emory University. Participants health outcomes are followed starting from hospital discharge, then at 30 days, 6 months, 12 months, and annually up to 5 years afterward. Researchers monitor events including target lesion failure, heart attacks, death, repeat procedures, vessel failure, thrombosis, and bleeding. This long-term observation helps to understand the safety and effectiveness of drug-coated balloons in real-world medical practice.

ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)