Study of DESyne X2 Drug-Eluting Stent for Coronary Artery Disease in Routine Care A Multicenter, Prospective Observational Study

What this Trial Is About

This research aims to evaluate the effectiveness and safety of the DESyne X2, a novolimus-eluting coronary stent, in routine clinical practice. The study focuses on patients with coronary stenosis, coronary occlusion, or coronary disease and observes their outcomes over time. It is a multicenter, prospective observational study designed to gather real-world data on this device. Participants are those who have undergone intervention with the DESyne X2 stent. The study does not involve randomization or treatment assignment but follows patients who received this particular stent as part of their care. The main outcome measured is the composite event rate within one year, with secondary outcomes including various cardiac events and procedural success tracked up to five years. During the study, participants will be monitored over several years for outcomes such as death, myocardial infarction, revascularization procedures, stent thrombosis, and stroke. Data will be collected according to routine clinical visits, and safety outcomes are observed without altering standard medical care. The total participation duration extends up to the study completion date in 2031, with primary outcome assessment at one year and longer-term follow-up continuing for several years.

IRIS- DESyne X2 in the IRIS-DES Registry