Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes

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.

NCT Number	NCT07563231
Lead Sponsor	Dorian Garin
Conditions	Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Stent Thrombosis, Percutaneous Coronary Intervention
Enrollment	300 participants
Start Date	2026-06
Primary Completion	2028-06 (estimated)
Study Completion	2036-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-09