Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry

Recruiting now

Conditions studied: Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT07256249

Run by

Fundación EPIC

People needed

960

Starts

2025-12-11

Expected to finish

2027-01-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Express refusal of the patient to participate in the study
• Life expectancy of the patient of less than 12 months

Where it is running

• Hospital Prof. Doutor Fernando da Fonseca — Amadora, Portugal (enrolling)
• Hospital de Santa Cruz — Carnaxide, Portugal (enrolling)
• Hospital de Faro — Faro, Portugal (enrolling)
• Hospital Universitario de Pontevedra — Vilagarcía de Arousa, Pontevedra, Spain (enrolling)
• Hospital Universitari Germans Trias i Pujol — Badalona, Spain (enrolling)
• Hospital del Mar — Barcelona, Spain (enrolling)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (enrolling)
• Hospital Universitario de Canarias — San Cristóbal de La Laguna, Spain (enrolling)
• Hospital Universitario Marqués de Valdecilla — Santander, Spain (enrolling)
• Hospital Clinico Universitario de Santiago — Santiago de Compostela, Spain (enrolling)
• Hospital Universitario Virgen del Rocio — Seville, Spain (enrolling)
• Hospital Universitari MútuaTerrassa — Terrassa, Spain (enrolling)
• Hospital Universitario de Torrevieja — Torrevieja, Spain (enrolling)

Full record on ClinicalTrials.gov

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