Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System in Patients with Coronary Artery Disease A Real-World Safety and Effectiveness Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Supraflex Family sirolimus-eluting coronary stent system in patients needing stent implantation for coronary artery disease. This observational registry study focuses on a real-world patient population to understand how this stent performs outside of tightly controlled clinical trials. The study is sponsored by Sahajanand Medical Technologies Limited and aims to gather important safety and efficacy data with the new stent design. The Supraflex stent features a biodegradable polymer coating on a cobalt-chromium platform, designed to improve long-term safety and flexibility compared to earlier stainless steel stents. Patients receive at least one Supraflex Family sirolimus-eluting stent as part of their usual clinical care. The study observes patients after their stent implantation without altering their treatment, focusing on real-world use. Follow-up is planned to track outcomes over time. Participants will be monitored for outcomes including target lesion failure, major cardiac events, stent thrombosis, deaths, heart attacks, and repeat procedures over a 12-month period. Researchers will collect medical information and assess patients through scheduled follow-up visits to gather this data. The study does not involve extra treatments but tracks patient progress to better understand the stents performance in everyday clinical use.

S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System