Observational Study of the SELUTION Sirolimus-eluting Balloon for Treating Coronary Artery Disease in Real-World Patients

What this Trial Is About

Researchers are observing patients with coronary artery disease who are being treated with the SELUTION SLRTM sirolimus-coated balloon. This study follows a group of real-world patients in multiple centers internationally to evaluate how this device performs in treating native coronary artery lesions and in-stent restenosis, focusing on its safety and effectiveness. The main goal is to assess major adverse cardiovascular events over 12 months, including death, heart attacks, or need for further treatment. Participants receive treatment with the SELUTION SLRTM device as decided by their doctors, targeting lesions in native vessels, coronary grafts, or restenosis cases. This is an observational study without a control group, meaning all participants receive the treatment as part of routine care. The study tracks outcomes over a year following the use of the device to gather real-world data. Throughout the study, participants undergo clinical follow-up to monitor cardiovascular events, device-related complications, and other health measures. Researchers collect data on major adverse cardiovascular events, target lesion revascularization, and specific composite endpoints at 12 months. Safety and success of the procedure are also recorded, with follow-ups continuing up to 12 months after treatment. Participation spans about one year from treatment to final assessments.

Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry