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

Recruitingn/aAges 18 Years - anyAllFundación EPIC
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In plain words

What the trial is, and whether it could suit you

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 Orien

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📋 Eligibility rules (as published)
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
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What it tests

  • SELUTION SLRTM sirolimus coated balloon
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Where

16 sites
Hospital Prof. Doutor Fernando da Fonseca
Amadora, Portugal
Hospital de Santa Cruz
Carnaxide, Portugal
Hospital Universitario de Coimbra
Coimbra, Portugal
Hospital de Faro
Faro, Portugal
ULS TAMEGA e SOUSA
Penafiel, Portugal
Hospital Universitario de Pontevedra
Vilagarcía de Arousa, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital del Mar
Barcelona, Spain

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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