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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitari MútuaTerrassa
RECRUITING
Terrassa
Hospital Universitario de Torrevieja
RECRUITING
Torrevieja
Contact Information
Primary
ORIOL RODRIGUEZ LEOR, MD, PhD
oriolrodriguez@gmail.com
0034934978989
Backup
FUNDACION EPIC
iepic@fundacionepic.org
0034987876135
Time Frame
Start Date: 2025-12-11
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 960
Treatments
Coronary Artery Disease (CAD)
Sponsors
Leads: Fundación EPIC

This content was sourced from clinicaltrials.gov