Long-Term Safety and Effectiveness Study of Drug-Eluting Balloon Angioplasty in Patients with Coronary Artery Disease

What this Trial Is About

Researchers are observing patients with coronary artery disease who have been treated with drug-eluting balloons in real-world clinical settings. The study aims to evaluate the long-term safety and effectiveness of this treatment approach by monitoring outcomes over several years. This multicenter prospective cohort study provides insights into routine clinical practice for angioplasty using drug-eluting balloons. Participants in this study have undergone balloon angioplasty with drug-eluting balloons after a predilatation procedure that leaves residual stenosis at 30% or less, without vessel dissection or interrupted blood flow. The study follows patients who are 20 years or older and have consented to participate, tracking their health outcomes without assigning specific treatments since it is observational. Throughout the study, participants health will be monitored for up to five years to assess various outcomes such as composite cardiovascular events, cardiac and all-cause death, myocardial infarction, target vessel and lesion revascularization, stent thrombosis, and stroke. Procedural success is also evaluated within three days after angioplasty. Regular follow-ups and data collection are conducted to understand the long-term impact and safety of drug-eluting balloon treatment in everyday practice.

Drug-Eluting Balloon Registry in Routine Clinical Practice