Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes
NCT: NCT07563231 · NOT_YET_RECRUITING
Brief 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.
Frequently Asked Questions
What is Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes?
Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes is a clinical trial registered under NCT07563231. Current status: NOT_YET_RECRUITING.
What is the status of NCT07563231?
The current status of NCT07563231 (Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes) is: NOT_YET_RECRUITING.
When did Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes start?
Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes started on 2026-06.
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Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.