Further Evaluation of Safety and Performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch™ Aortic Arch Stent Graft System

Last updated: November 26, 2025
Sponsor: Endospan Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05636527
CIP010
  • Ages > 18
  • All Genders

Study Summary

The goal of this observational study is to collect clinical information on how safe, and how well the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System work for the treatment of aortic aneurysms, in the standard-of-care setting.

The main question[s] it aims to answer are:

  • Early mortality

  • Safety outcomes throughout the study

  • Device failure throughout the study

  • Procedural and hospitalisation information Participants will be treated per institutional standard of care Follow-up information will be collected through to five years.

Eligibility Criteria

Inclusion

  1. Male and female age ≥18 years

  2. The subject is indicated for implant of the NEXUS Aortic Arch System in accordance with the current IFU, or

  3. The subject is indicated for implant of the custom-made NEXUS DUO Aortic Arch System in accordance with the current IFU, or

  4. The subject has been already implanted, after February 2019, with the NEXUS or the NEXUS DUO according to the relevant IFU

  5. The subject is able and willing to provide informed consent to participate in the study.

  6. Subject is not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.

  7. In the opinion of the Investigator, life expectancy exceeds one year

  8. The subject is not pregnant or planning to become pregnant.

  9. In the physician's opinion, subject's renal function is stable for the NEXUS procedure.

  10. In the opinion of the investigator, subject does not have co-morbidities or planned surgeries that will interfere with the implant of the device, e.g., major cardiac surgery or interventional procedure in the last 90 days, MI or cerebral vascular accident (CVA) in the last 90 days

Study Design

Total Participants: 70
Study Start date:
November 09, 2022
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • Cliniques universitaires Saint Luc

    Brussels 2800866, 1200
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven 2792482, 3000
    Belgium

    Active - Recruiting

  • Aretaieio Hospital

    Nicosia 146268, Cyprus 2024
    Cyprus

    Active - Recruiting

  • APHP Henri Mondor

    Paris,
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou

    Paris,
    France

    Active - Recruiting

  • APHP Henri Mondor

    Paris 2988507,
    France

    Active - Recruiting

  • Hôpital Européen Georges Pompidou

    Paris 2988507,
    France

    Active - Recruiting

  • Immanuel Klinikum Brandenburg, Herzzentrum Brandenburg

    Bernau bei Berlin 2950096, Brandenburg 2945356 16321
    Germany

    Active - Recruiting

  • University Hospital Duesseldorf

    Düsseldorf 2934246, North Rhine-Westphalia 2861876 40225
    Germany

    Active - Recruiting

  • University Hospital Duesseldorf

    Duesseldorf, North-Rhine-Westphalia 40225
    Germany

    Site Not Available

  • German Heart Center

    Berlin,
    Germany

    Site Not Available

  • German Heart Center

    Berlin 2950159,
    Germany

    Active - Recruiting

  • University Hospital Bonn

    Bonn,
    Germany

    Site Not Available

  • University Hospital Bonn

    Bonn 2946447,
    Germany

    Active - Recruiting

  • Evaggelismos General Hospital

    Athens,
    Greece

    Site Not Available

  • Evaggelismos General Hospital

    Athens 264371,
    Greece

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia

    Brescia 3181554, 25123
    Italy

    Site Not Available

  • University Hospital Padoua

    Padova,
    Italy

    Site Not Available

  • University Hospital Padoua

    Padua 3171728,
    Italy

    Active - Recruiting

  • Stichting Amsterdam UMC,

    Amsterdam 2759794, 1081
    Netherlands

    Active - Recruiting

  • University Medical Center Groningen

    Groningen 2755251,
    Netherlands

    Site Not Available

  • Medical University of Warsaw

    Warsaw,
    Poland

    Site Not Available

  • Medical University of Warsaw

    Warsaw 756135,
    Poland

    Active - Recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz, Andalucia 11009
    Spain

    Site Not Available

  • Hospital Universitario Puerta del Mar

    Cadiz 2520600, Andalusia 2593109 11009
    Spain

    Active - Recruiting

  • Hospital Alvaro Cunqueiro Vigo

    Vigo, Galicia 36312
    Spain

    Site Not Available

  • Hospital Alvaro Cunqueiro Vigo

    Vigo 3105976, Galicia 3336902 36312
    Spain

    Active - Recruiting

  • Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich

    Zurich 2657896,
    Switzerland

    Active - Recruiting

  • Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich

    Zürich,
    Switzerland

    Site Not Available

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