Coroflex4 ISAR NEO Coronary Stent System Post-Market Follow-up Study Evaluating Safety and Performance in Real-World Use for Coronary Artery Disease

What this Trial Is About

Researchers are conducting an international, multicenter, prospective, non-randomized post-market clinical follow-up PMCF study to confirm and support the clinical safety and performance of the Coroflex4 ISAR NEO coronary stent system, which is a sirolimus-eluting stent. This study includes all consecutive patients treated with this stent in a real-world, non-selected population under daily clinical practice to meet EU Medical Device Regulation requirements. Participants receive treatment with the Coroflex4 ISAR NEO coronary stent system as intended by the manufacturer during their standard care for coronary artery disease or ischemic heart disease. The study observes patients treated with this device without randomization or control groups, focusing on its use in routine medical settings. During the study, participants will be monitored for safety and efficacy outcomes, including freedom from target lesion failure within 7 days after the procedure. Additional safety measures during percutaneous coronary intervention PCI will be tracked, such as avoiding stent dislodgement, balloon rupture, hypotube rupture, coronary perforation, coronary dissection, no reflow, and coronary thrombosis. The study involves informed consent and follows patients outcomes under normal clinical conditions until study completion.

Coroflex® ISAR NEO PMCF Study