Evaluation of Ultrathin Strut Sirolimus-eluting Stent with Bioabsorbable Polymer in Patients on Long-term Oral Anticoagulation Undergoing Coronary Revascularization

What this Trial Is About

This research focuses on patients with coronary artery disease and ischemic heart disease who are receiving chronic oral anticoagulation and need percutaneous coronary revascularization with stent implantation. Because these patients require antiplatelet therapy, they face a high risk of bleeding. The study evaluates a new generation ultrathin strut sirolimus-eluting stent with a bioabsorbable polymer, which may allow for shorter antiplatelet treatment regimens and could be a suitable option for these high-bleeding risk patients. Participants receive treatment using the Supraflex Cruz Sirolimus-eluting stent during a percutaneous coronary intervention PCI for de novo coronary artery stenosis. This observational study monitors patients who have had this specific stent implanted, without randomization or placebo comparison, focusing on the real-world use of this device. No other stents are used within 6 months before or during the procedure, and the stent is the single device evaluated. During the study, participants are followed for up to 12 months to assess outcomes such as Net Adverse Clinical Events NACE, Major Adverse Cardiac Events MACE, Target Lesion Failure TLF, death, acute myocardial infarction, stroke, and target vessel revascularization. Follow-up includes monitoring clinical events and ensuring participant safety. The total study duration extends until March 2029, with a primary completion date in March 2027.

Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation