Follow-up of a polymer-free sirolimus stent in adults with coronary artery disease
Follows adults who received a polymer-free sirolimus stent during a heart artery procedure.
Plain-language title generated from the registry record
Registry title: Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes
Key facts
- Where
- Geneva, SwitzerlandSee the site
Where in Switzerland
- Geneva University Hospitals (HUG) - Service of CardiologyGeneva, SwitzerlandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Dorian Garin
- Trial code
- NCT07563231
- Record updated
- 9 June 2026
- Original description
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.Read full original descriptionShow less
POLARIS : 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.
Inclusion: 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; Able and willing to provide written informed consent; Sufficient knowledge of French, German, English, or Italian to understand the patient information document.
Exclusion: Inability to provide informed consent (cognitive impairment or other); Life expectancy less than 12 months due to non-cardiac comorbidities at the time of consent; Documented refusal to participate in research through opt-out from general consent; Inability to be contacted for informed consent (no valid contact information, or unreachable after three contact attempts); Participation in another clinical trial that would interfere with the endpoints of this registry.