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.
Age >= 18 years at the time of the index procedure.
Percutaneous coronary intervention performed at Geneva University Hospitals between January 2021 and December 2025.
Implantation of at least one study device
Indication for PCI according to current European or American guidelines.
Documented refusal to participate in research through opt-out from general consent.
Inability to provide informed consent (cognitive impairment or other).
Inability to be contacted for informed consent (no valid contact information, or unreachable after three contact attempts).
Life expectancy less than 12 months due to non-cardiac comorbidities at the time of consent.
Consecutive adult patients who underwent percutaneous coronary intervention with implantation of at least one ABLUMINUS NP sirolimus-eluting stent at Geneva University Hospitals between January 2021 and December 2025.
Cohort
Prospective
Polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA)
DeviceThin-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.
Target Lesion Failure (TLF)
Device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation, defined per Academic Research Consortium-2 (ARC-2) criteria. Binary categorical variable analysed by time-to-first-event method.
Target Lesion Failure (TLF) at 2 and 5 years
Same ARC-2 composite definition as primary endpoint, assessed at 2 and 5 years.
Cardiac death
Target vessel myocardial infarction
Myocardial infarction attributable to the target vessel, defined per ARC-2 and the 4th Universal Definition of Myocardial Infarction.
Clinically indicated target lesion revascularisation
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Dorian Garin
Lead sponsor
University Hospital, Geneva
Sponsor institution
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