Evaluation of the Polymer-Free Sirolimus Eluting Vivo ISAR Coronary Stent System in Real-World Patients with Coronary Artery Disease

What this Trial Is About

This observational study evaluates the Polymer Free Sirolimus Eluting Coronary Stent System, known as the Vivo ISAR, in everyday clinical practice for patients with coronary artery stenosis. The purpose is to collect real-world data on clinical outcomes over a 12-month follow-up period, focusing on patients who receive this stent system as part of their routine care. The study is sponsored by Translumina GmbH and involves standard procedures and medications with known safety profiles. Participants will be treated with the Vivo ISAR stent during percutaneous coronary intervention to improve coronary artery diameter in those experiencing symptoms of ischemic heart disease. The study monitors patients who receive the stent in one or multiple vessels, observing their progress without altering standard care practices. The follow-up extends to 12 months after the procedure to assess various success rates and treatment effects. During the study, participants undergo routine clinical evaluations including assessments of device and procedural success shortly after treatment, and measures of target lesion failure and reperfusion at 12 months. Researchers also evaluate antiplatelet therapy adherence and effectiveness. The total participation involves regular check-ups and data collection to understand long-term outcomes and safety of the Vivo ISAR stent system in typical healthcare settings.

Evaluation of the Vivo Isar Stent System in Routine Clinical Practice