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ABLUMINUS NP Polymer Free Sirolimus-Eluting Stent Registry at Geneva University Hospitals (ABLUMINUS-GVA) (ABLUMINUS-GVA)

24. april 2026 opdateret af: Dorian Garin

ABLUMINUS-GVA: A Pilot Registry Evaluating the Real-World Safety and Efficacy of the ABLUMINUS NP Polymer-Free Sirolimus-Eluting Stent at Geneva University Hospitals

ABLUMINUS-GVA is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the ABLUMINUS NP polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI) at Geneva University Hospitals. 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. Approximately 50 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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 ABLUMINUS NP (Concept Medical, Tampa, FL, USA) 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 ABLUMINUS NP 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 ABLUMINUS NP stent at Geneva University Hospitals between January 2021 and December 2025, 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. Anticipated enrolment approximately 50 patients.

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Schweiz
      • Geneva, Schweiz, 1211
        • Geneva University Hospitals (HUG) - Service of Cardiology
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Juan F Iglesias, MD, FESC, FACC
        • Underforsker:
          • Dorian Garin, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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 ABLUMINUS NP sirolimus-eluting stent.
  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
ABLUMINUS NP cohort
Consecutive adult patients who received at least one ABLUMINUS NP 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.
Enhed: ABLUMINUS NP polymer-free sirolimus-eluting stent
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Target Lesion Failure (TLF)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Target Lesion Failure (TLF) at 2 and 5 years
Tidsramme: 2 years; 5 years
Same ARC-2 composite definition as primary endpoint, assessed at 2 and 5 years.
2 years; 5 years
Cardiac death
Tidsramme: 30 days; 12 months; 2 years; 5 years
30 days; 12 months; 2 years; 5 years
Target vessel myocardial infarction
Tidsramme: 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
Tidsramme: 30 days; 12 months; 2 years; 5 years
30 days; 12 months; 2 years; 5 years
Patient-oriented composite endpoint (POCE)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 12 months; 2 years; 5 years
12 months; 2 years; 5 years
All-cause mortality
Tidsramme: 12 months; 2 years; 5 years
12 months; 2 years; 5 years
Late lumen loss (mm)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dorian Garin

Efterforskere

  • Ledende efterforsker: Juan F Iglesias, MD, FESC, FACC, Geneva University Hospitals (HUG), Interventional Cardiology Unit
  • Studieleder: Dorian Garin, MD, Geneva University Hospitals (HUG), Department of Cardiology

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juni 2032

Datoer for studieregistrering

Først indsendt

24. april 2026

Først indsendt, der opfyldte QC-kriterier

24. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ABLUMINUS-GVA-2026
  • ABLUMINUS-GVA v1 04.03.2026 (Anden identifikator: Sponsor-Investigator protocol version)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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