Global Registry to Confirm Safety and Performance of the Elixir Medical DynamX Coronary Bioadaptor System in Treating Coronary Artery Disease

What this Trial Is About

This research aims to gather more information on the safety, effectiveness, and performance of the DynamX Coronary Bioadaptor System in treating patients with ischemic heart disease caused by new native coronary artery lesions. It focuses on a real-world patient population with coronary artery disease to confirm how well this device works and its safety when used in routine medical care. All participants in the study will receive at least one implant of the DynamX Novolimus-eluting Coronary Bioadaptor System during a percutaneous coronary intervention PCI procedure. The device will be used following the products instructions in a commercial setting. This registry monitors the devices performance and outcomes over time without altering the usual care process. During the study, patients will be followed to assess clinical outcomes such as device success, procedural success, and various cardiovascular events including myocardial infarction, revascularization, stroke, and death. These outcomes will be tracked at hospital stay, 30 days, and 12 months after the procedure. The study also collects data on the duration of dual antiplatelet therapy DAPT and will monitor device safety and effectiveness throughout the follow-up period, which extends up to 12 months and beyond.

DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System