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Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes
Sponsor: Dorian Garin
Summary
POLARIS is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI). The primary endpoint is target lesion failure (TLF) at 12 months, defined per Academic Research Consortium-2 (ARC-2) criteria as the device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. Patients treated since January 2021 will be retrospectively identified and prospectively consented, with follow-up through 5 years. The registry will provide the first Western clinical evidence on this CE-marked device and serve as a template for a future national Swiss multicentre registry.
Official title: POLARIS : POLymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2026-06
Completion Date
2036-06
Last Updated
2026-06-09
Healthy Volunteers
No
Conditions
Interventions
Polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA)
Thin-strut (73 micrometres) cobalt-chromium coronary stent with polymer-free submicron phospholipid carriers (200-300 nm) delivering sirolimus exclusively to the abluminal surface, and fusion coating extending sirolimus deposition up to 5 mm beyond the stent edges. CE-marked 24 January 2020. Available diameters 2.25-4.0 mm and lengths 8-40 mm. Manufactured by Concept Medical, Tampa, FL, USA. Implantation and peri-procedural care follow operator discretion and institutional standard of care.
Locations (1)
Geneva University Hospitals (HUG) - Service of Cardiology
Geneva, Switzerland