Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes

Sponsor
Dorian Garin
Study ID
NCT07563231
Status
Not Yet Recruiting

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Conditions

  • Acute Coronary Syndrome
  • Coronary Artery Disease
  • Myocardial Infarction
  • Percutaneous Coronary Intervention
  • Stent Thrombosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) — DEVICE
    Thin-strut (73 micrometres) cobalt-chromium coronary stent with polymer-free submicron phospholipid carriers (200-300 nm) delivering sirolimus exclusively to the abluminal surface, and fusion coating extending sirolimus deposition up to 5 mm beyond the stent edges. CE-marked 24 January 2020. Available diameters 2.25-4.0 mm and lengths 8-40 mm. Manufactured by Concept Medical, Tampa, FL, USA. Implantation and peri-procedural care follow operator discretion and institutional standard of care.

Study Details

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 Dates

First listed
May 1, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2036

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: POLARIS cohort
    Consecutive adult patients who received at least one polymer-free sirolimus-eluting stent during PCI at Geneva University Hospitals between January 2021 and December 2025. No study-mandated procedures; clinical care follows standard institutional practice.

Primary Outcome Measure

Target Lesion Failure (TLF) [ Time Frame: 12 months ]

Central Contacts

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