Randomized Study Comparing Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent to Durable Polymer Everolimus-eluting Stents in Patients Undergoing Percutaneous Coronary Intervention

What this Trial Is About

Researchers are comparing the safety and effectiveness of two types of everolimus-eluting stents used in patients with coronary artery stenosis treated with percutaneous coronary intervention PCI. The study focuses on a new ultra-low strut thickness biodegradable polymer stent called Evermine50 and compares it with established durable polymer everolimus-eluting stents, Xience or Promus. This randomized study aims to evaluate these devices in a broad patient population undergoing PCI to improve treatment options for coronary artery disease and ischemia. Participants will receive either the ultra-low strut thickness biodegradable Evermine50 stent or one of the durable polymer everolimus-eluting stents Xience or Promus during their PCI procedure. The study involves two groups one treated with the Evermine50 stent experimental arm and the other with the durable polymer stents comparator arm. The interventions consist of placing these drug-eluting stents to open narrowed coronary arteries and restore blood flow. During the study, researchers will monitor participants for up to five years, focusing on key outcomes such as target lesion failure at one year, and tracking all-cause death, cardiac death, myocardial infarction, stent thrombosis, and repeat revascularization at one, three, and five years. Participants will undergo regular evaluations to assess the safety and effectiveness of the stents. The total duration of involvement varies, with follow-up visits scheduled over several years to gather comprehensive safety and efficacy data.

Comparison of an Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent Versus Durable Polymer Everolimus-eluting Stents in Patients Treated with Percutaneous Coronary Intervention