SIROOP Registry A Study on Outcomes in Coronary Artery Disease Patients Treated with Sirolimus or Paclitaxel Coated Balloon Catheters

What this Trial Is About

Researchers are evaluating clinical outcomes in patients with coronary artery disease who have undergone percutaneous coronary intervention PCI using drug-coated balloons DCBs with either sirolimus or paclitaxel coatings. This prospective registry study aims to collect both retrospective and prospective data on baseline characteristics, procedural details, and clinical outcomes across various patient groups, including those with different coronary artery lesions and clinical presentations. The study focuses on assessing the impact of these DCBs on cardiovascular outcomes and identifying optimal treatment strategies. Participants receive treatment using currently available sirolimus or paclitaxel eluting balloon catheters during PCI, with device choice left to the operator. Data collected includes procedural success, complications, and performance of various DCBs alone or combined with other stents or scaffolds. The study also investigates lesion preparation methods, predictors of target lesion revascularization, angiographic and imaging findings, antithrombotic regimens, and economic implications of interventional treatments in coronary artery disease. Participants data will be monitored over time for clinical outcomes such as myocardial infarction, unstable angina, target lesion failure and revascularization, stroke, bleeding, heart failure, and mortality at intervals including 180 days, 1, 2, and 5 years. Procedural details, complications, and long-term outcomes will be recorded and analyzed. The primary outcome measure is the rate of target lesion failure and revascularization at one year. This long-term observational study involves ongoing data collection to evaluate the safety and performance of DCBs in real-world clinical settings.

SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters