Actively Recruiting
Study of the Biodegradable Polymer-Coated Sirolimus-Eluting Stent in Patients with Multivessel Coronary Artery Disease
Led by Sahajanand Medical Technologies Limited · Updated on 2026-04-27
1000
Participants Needed
2
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are observing the safety and clinical performance of the biodegradable polymer-coated Supraflex Cruz Sirolimus-eluting Stent in patients with multivessel coronary artery disease who need coronary revascularization using drug-eluting stents. This study includes a broad group of patients reflecting everyday clinical practice, including those with chronic coronary artery disease and acute coronary syndromes such as STEMI and NSTEMI. It aims to gather real-world data on this stents use in multiple vessel treatments. The study involves the use of the Supraflex Cruz Sirolimus-eluting Coronary Stent System, which is a biodegradable polymer-coated cobalt-chromium stent releasing sirolimus. All treated vessels will exclusively receive this stent during the procedure. Patients are followed according to routine clinical practice, with scheduled follow-ups either by phone or in person at 30 days, 6 months, and 12 months after the initial procedure. The study also plans subgroup analyses based on clinical presentation and lesion characteristics. Participants will undergo standard clinical evaluations and follow-up visits over one year to monitor outcomes such as Target Lesion Failure, mortality, myocardial infarction, revascularization, stent thrombosis, and target vessel failure. Follow-ups are designed to align with regular care schedules and include telephonic or clinical assessments. The total participation time for each patient is approximately 12 months, allowing researchers to collect comprehensive data on stent performance and patient safety in a real-world setting.
CONDITIONS
Brief Title
CRUZ Tunisia-Multivessel Registry
Research Team
P
Prof. Nadhem HAJLAOUI
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