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

5 juin 2026 mis à jour par: Dorian Garin

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

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

BACKGROUND. Newer-generation drug-eluting stents (DES) remain associated with late stent-related adverse events at approximately 2% per year, driven by neoatherosclerosis, delayed endothelial healing, and chronic inflammation attributable to permanent polymer coatings. Polymer-free DES were developed to remove this substrate. The polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) (after: study device) is a novel polymer-free sirolimus-eluting stent built on a thin-strut (73 micrometres) cobalt-chromium platform, with drug delivery via biodegradable phospholipid submicron carriers (200-300 nm) confined to the abluminal surface, and a proprietary fusion coating extending sirolimus up to 5 mm beyond the stent edges. The device received CE marking on 24 January 2020. Only limited non-randomized Indian clinical data exist; no Western clinical data have been published.

OBJECTIVES. Primary: to evaluate device-oriented safety and efficacy (TLF at 12 months) of the stent in an all-comer population undergoing PCI at Geneva University Hospitals. Secondary: TLF at 2 and 5 years; individual components of TLF (cardiac death, target vessel MI, clinically indicated target lesion revascularisation) at 30 days, 12 months, 2 years, and 5 years; patient-oriented composite endpoint (all-cause death, any MI, any revascularisation); stent thrombosis (definite / probable, ARC-2, with temporal classification); target vessel failure; major bleeding (BARC 3 or 5); all-cause mortality; and late lumen loss when angiographic follow-up is available.

DESIGN. Prospective, single-centre, single-arm observational registry (Category A research with human subjects per the Swiss Human Research Act). Hybrid enrolment: retrospective identification from January 2021, prospective consent, and prospective follow-up at 30 days, 12 months, 2 years, and 5 years via medical records and telephone interview.

POPULATION. All consecutive adult patients (>= 18 years) treated with at least one study device stent at Geneva University Hospitals since January 2021, with an indication for PCI according to current European or American guidelines, able to provide written informed consent, and with sufficient knowledge of French, German, English, or Italian.

STATISTICS. Exploratory, descriptive analysis. Binary endpoints with Clopper-Pearson 95% confidence intervals; time-to-event analysis by Kaplan-Meier with Greenwood 95% CIs. Pre-specified exploratory subgroup analyses (sex, clinical presentation, diabetes, age, lesion complexity, stent length) presented as forest plots without between-group p-values. Sensitivity analyses include per-protocol, complete-case, landmark (30 days to 12 months), Fine-Gray competing-risk, and tipping point analyses. Analyses in Python (lifelines, pandas, scipy, statsmodels). Reporting follows STROBE.

Type d'étude

Observationnel

Inscription (Estimé)

300

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Suisse
      • Geneva, Suisse, 1211
        • Geneva University Hospitals (HUG) - Service of Cardiology
        • Contact:
        • Contact:
        • Chercheur principal:
          • Juan F Iglesias, MD, FESC, FACC
        • Sous-enquêteur:
          • Dorian Garin, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Consecutive adult patients who underwent percutaneous coronary intervention with implantation of at least one ABLUMINUS NP sirolimus-eluting stent at Geneva University Hospitals between January 2021 and December 2025.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Dispositif: Polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA)
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Target Lesion Failure (TLF)
Délai: 12 months
Device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation, defined per Academic Research Consortium-2 (ARC-2) criteria. Binary categorical variable analysed by time-to-first-event method.
12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Target Lesion Failure (TLF) at 2 and 5 years
Délai: 2 years; 5 years
Same ARC-2 composite definition as primary endpoint, assessed at 2 and 5 years.
2 years; 5 years
Cardiac death
Délai: 30 days; 12 months; 2 years; 5 years
30 days; 12 months; 2 years; 5 years
Target vessel myocardial infarction
Délai: 30 days; 12 months; 2 years; 5 years
Myocardial infarction attributable to the target vessel, defined per ARC-2 and the 4th Universal Definition of Myocardial Infarction.
30 days; 12 months; 2 years; 5 years
Clinically indicated target lesion revascularisation
Délai: 30 days; 12 months; 2 years; 5 years
30 days; 12 months; 2 years; 5 years
Patient-oriented composite endpoint (POCE)
Délai: 12 months; 2 years; 5 years
Composite of all-cause death, any myocardial infarction, and any revascularisation.
12 months; 2 years; 5 years
Definite or probable stent thrombosis (ARC-2)
Délai: Acute (0-24h), subacute (1-30d), late (30d-1y), very late (>1y), up to 5 years
Acute (0-24h), subacute (1-30d), late (30d-1y), very late (>1y), up to 5 years
Target vessel failure (TVF)
Délai: 12 months; 2 years; 5 years
Composite of cardiac death, target vessel myocardial infarction, and clinically indicated target vessel revascularisation.
12 months; 2 years; 5 years
Major bleeding (BARC type 3 or 5)
Délai: 12 months; 2 years; 5 years
12 months; 2 years; 5 years
All-cause mortality
Délai: 12 months; 2 years; 5 years
12 months; 2 years; 5 years
Late lumen loss (mm)
Délai: At clinically indicated follow-up angiography, up to 5 years
In-stent late lumen loss by quantitative coronary angiography, assessed only in patients undergoing clinically indicated follow-up angiography.
At clinically indicated follow-up angiography, up to 5 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dorian Garin

Les enquêteurs

  • Chercheur principal: Juan F Iglesias, MD, FESC, FACC, Geneva University Hospitals (HUG), Interventional Cardiology Unit
  • Directeur d'études: Dorian Garin, MD, Geneva University Hospitals (HUG), Department of Cardiology

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juin 2028

Achèvement de l'étude (Estimé)

1 juin 2036

Dates d'inscription aux études

Première soumission

24 avril 2026

Première soumission répondant aux critères de contrôle qualité

24 avril 2026

Première publication (Réel)

1 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • POLARIS (Alias Study Number)
  • POLARIS v1 04.03.2026 (Autre identifiant: Sponsor-Investigator protocol version)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Anonymised individual participant data may be made available to other researchers upon reasonable written request addressed to the sponsor-investigator after publication of the primary 12-month results, subject to a data sharing agreement and approval by the competent ethics committee.

Délai de partage IPD

Starting 6 months after publication of the primary 12-month results, without predefined end date.

Critères d'accès au partage IPD

Reasonable written request to the sponsor-investigator; institutionally approved research protocol; signed data sharing agreement; approval of the competent cantonal ethics committee.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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