Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes
Starting soon
Conditions studied: Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Stent Thrombosis, Percutaneous Coronary Intervention
In brief
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.
Key facts
- Study ID
- NCT07563231
- Run by
- Dorian Garin
- People needed
- 300
- Starts
- 2026-06-01
- Expected to finish
- 2036-06-01
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Participation in another clinical trial that would interfere with the endpoints of this registry.
Where it is running
- Geneva University Hospitals (HUG) - Service of Cardiology — Geneva, Switzerland
Full record on ClinicalTrials.gov
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