Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected real-world patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR (in-stent restenosis) in all settings, in order to evaluate its effectiveness and safety. The primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected real-world patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.
• Patients with age ≥18 years and;
• Patients with coronary artery disease in whom, at the operator's discretion, treatment of a lesion in a native vessel, coronary graft or coronary restenosis is decided using the Selution SLRTM device;
• Patient who has been informed of the characteristics of the study and has provided written informed consent.