[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636249":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":29,"locations":36,"responsibleParty":55,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":72,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":89,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"POLARIS cohort",null,"Consecutive adult patients who received at least one polymer-free sirolimus-eluting stent during PCI at Geneva University Hospitals between January 2021 and December 2025. No study-mandated procedures; clinical care follows standard institutional practice.",[13],"Device: Polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","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.",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Juan F Iglesias, MD, FESC, FACC","Geneva University Hospitals (HUG), Interventional Cardiology Unit","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":28},"Dorian Garin, MD","Geneva University Hospitals (HUG), Department of Cardiology","STUDY_DIRECTOR",[30,34],{"name":22,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","+41 22 372 72 00","juanFernando.Iglesias@hug.ch",{"name":26,"role":31,"phone":10,"phoneExt":10,"email":35},"dorian.garin@hug.ch",[37],{"facility":38,"status":10,"city":39,"state":10,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Geneva University Hospitals (HUG) - Service of Cardiology","Geneva","1211","Switzerland","CH",{"type":44,"coordinates":45},"Point",[46,47],6.14569,46.20222,{"lat":47,"lon":46},[50,51,52,53],{"name":22,"role":31,"phone":32,"phoneExt":10,"email":33},{"name":26,"role":31,"phone":10,"phoneExt":10,"email":35},{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"name":26,"role":54,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Dorian Garin","Dr Dorian Garin, MD","100636249","polymer-free-sirolimus-eluting-stent-real-world-investigation-of-safety-and-outcomes-100636249",false,"NCT07563231","Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes","POLARIS : POLymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes","POLARIS","Inclusion Criteria:\n\n* Age \\>= 18 years at the time of the index procedure.\n* Percutaneous coronary intervention performed at Geneva University Hospitals between January 2021 and December 2025.\n* Implantation of at least one study device\n* Indication for PCI according to current European or American guidelines.\n* Able and willing to provide written informed consent.\n* Sufficient knowledge of French, German, English, or Italian to understand the patient information document.\n\nExclusion Criteria:\n\n* Documented refusal to participate in research through opt-out from general consent.\n* Inability to provide informed consent (cognitive impairment or other).\n* Inability to be contacted for informed consent (no valid contact information, or unreachable after three contact attempts).\n* Life expectancy less than 12 months due to non-cardiac comorbidities at the time of consent.\n* Participation in another clinical trial that would interfere with the endpoints of this registry.","ALL","18 Years",{"count":70,"type":71},300,"ESTIMATED","5 Years","OBSERVATIONAL","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.",[76,77,78,79,80],"Coronary Artery Disease","Acute Coronary Syndrome","Myocardial Infarction","Stent Thrombosis","Percutaneous Coronary Intervention",[82,83,84,85,86,87,88],"drug-eluting stent","polymer-free stent","sirolimus","percutaneous coronary intervention","target lesion failure","registry","real-world evidence","NOT_YET_RECRUITING","2026-06-05",{"date":92,"type":93},"2026-06-09","ACTUAL",{"date":95,"type":71},"2026-06",{"date":97,"type":71},"2036-06",{"name":57,"class":6},1]