Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes (NCT07563231) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes
Switzerland300 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a polymer-free sirolimus-eluting stent in real-world patients — how does a polymer-free design differ from the stent I might receive with standard care, and why might that difference matter for my situation?
2Since this trial is not yet recruiting, how long might it realistically be before I could even be considered for enrollment, and is waiting potentially risky given my current diagnosis?
3The trial's main outcome is something called Target Lesion Failure — can you explain what that means in plain terms, and how the rate being measured here would compare to what's expected with stents you'd typically use for me today?
4This study is listed as Phase NA, which I understand often means it's observational or a device registry rather than a traditional drug trial — does that change what risks I'd be taking on compared to just receiving standard stent treatment outside of the study?
5Given that my condition involves acute coronary syndrome or myocardial infarction, would you recommend I consider standard proven treatment options now rather than waiting for this trial to open, or do you think there's a genuine reason to revisit this study once it's recruiting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.