NCT07256249 Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
| NCT ID | NCT07256249 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación EPIC |
| Condition | Cardiovascular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 960 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 960 participants in total. It began in 2025-12-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07256249 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07256249 currently recruiting?
Yes, NCT07256249 is actively recruiting participants. Contact the research team at oriolrodriguez@gmail.com for enrollment information.
Where is the NCT07256249 trial being conducted?
This trial is being conducted at Amadora, Portugal, Carnaxide, Portugal, Faro, Portugal, Vilagarcía de Arousa, Spain and 10 additional locations.
Who is sponsoring the NCT07256249 clinical trial?
NCT07256249 is sponsored by Fundación EPIC. The trial plans to enroll 960 participants.