SELUTION sirolimus-eluting balloon for treating coronary artery blockages and in-stent restenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Prof. Doutor Fernando da Fonseca
  Amadora, Portugal Recruiting
• Hospital de Santa Cruz
  Carnaxide, Portugal Recruiting
• Hospital Universitario de Coimbra
  Coimbra, Portugal Recruiting
• Hospital de Faro
  Faro, Portugal Recruiting
• ULS TAMEGA e SOUSA
  Penafiel, Portugal Recruiting
• Hospital Universitario de Pontevedra
  Vilagarcía de Arousa, Pontevedra, Spain Recruiting

Study contacts

• Study coordinator: ORIOL RODRIGUEZ LEOR, MD, PhD
• Email: oriolrodriguez@gmail.com
• Phone: 0034934978989

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.