NCT07563231Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 24 Apr 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Dorian Garin
- Diseases
- Coronary artery disease
- NCT number
- NCT07563231
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Jun 2026 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Geneva University Hospitals (HUG) - Service of Cardiology Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.