SELUTION sirolimus-eluting balloon for treating coronary artery blockages and in-stent restenosis
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
This registry will try the SELUTION sirolimus-coated balloon in adults with coronary artery disease—including native vessel blockages and in-stent restenosis—to see how safe and effective it is in routine clinical practice.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 960 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 5 sites (Badalona and 4 other locations) |
| Trial ID | NCT07256249 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, international, observational registry enrolling consecutive real-world patients in whom the operator chooses the SELUTION SLRTM sirolimus-eluting balloon for native coronary lesions or in-stent restenosis. There is no control group and patients are followed longitudinally to capture outcomes and safety events. The primary endpoint is the incidence of major adverse cardiovascular events (MACE) at 12 months, including death, non-fatal myocardial infarction, or target lesion revascularization. Device- and patient-oriented composite endpoints will also be reported to detail device-related and overall clinical outcomes.
Who should consider this trial
Good fit: Adults (age ≥18) with coronary artery disease for whom the treating physician decides to use the SELUTION SLRTM balloon for a native vessel lesion, graft lesion, or in-stent restenosis who provide informed consent.
Not a fit: Patients who refuse participation, have a life expectancy under 12 months, or whose lesions are judged unsuitable for balloon-based therapy (for example requiring urgent bypass or other approaches) are unlikely to benefit from inclusion in this registry.
Why it matters
Potential benefit: If successful, the SELUTION balloon strategy could reduce rates of restenosis and the need for repeat procedures in selected coronary lesions.
How similar studies have performed: Previous registries and early trials of drug-coated balloons, including newer sirolimus-coated devices, have shown promising results for in-stent restenosis and selected native lesions, but large randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Badalona and 4 other locations
- Hospital Universitari Germans Trias i Pujol — Badalona, Spain (Recruiting)
- Hospital Universitario de Canarias — San Cristóbal de La Laguna, Spain (Recruiting)
- Hospital Universitario Marqués de Valdecilla — Santander, Spain (Recruiting)
- Hospital Universitari MútuaTerrassa — Terrassa, Spain (Recruiting)
- Hospital Universitario de Torrevieja — Torrevieja, Spain (Recruiting)
Study contacts
- Study coordinator: ORIOL RODRIGUEZ LEOR, MD, PhD
- Email: oriolrodriguez@gmail.com
- Phone: 0034934978989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.