Registry following adults with narrowed heart arteries treated with a drug-coated balloon
Follows adults with heart artery narrowing treated with a sirolimus-coated balloon.
Plain-language title generated from the registry record
Registry title: Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Key facts
- Where
- Amadora, Carnaxide, Coimbra, Faro, and Penafiel, PortugalSee the 5 sites
Where in Portugal
- Hospital Prof. Doutor Fernando da FonsecaAmadora, PortugalTaking people
- Hospital de Santa CruzCarnaxide, PortugalTaking people
- Hospital Universitário de CoimbraCoimbra, PortugalTaking people
- Hospital de FaroFaro, PortugalTaking people
- ULS TAMEGA e SOUSAPenafiel, PortugalTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación EPIC
- Trial code
- NCT07256249
- Record updated
- 29 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Express refusal of the patient to participate in the study; Life expectancy of the patient of less than 12 months.