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Recruiting
NCT07256249
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Conditions: Cardiovascular Diseases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 960
Sponsor: Fundación EPIC
Location: Hospital Universitari Germans Trias i Pujol Badalona
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Express refusal of the patient to participate in the study
* Life expectancy of the patient of less than 12 months
Source: ClinicalTrials.gov (NCT07256249). StuddyBuddy aggregates publicly available trial information.
