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

Last updated: August 27, 2024
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: 60
Study Start date:
November 09, 2022
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • APHP Henri Mondor

    Paris,
    France

    Active - Recruiting

  • Hôpital Européen Georges Pompidou

    Paris,
    France

    Active - Recruiting

  • University Hospital Duesseldorf

    Duesseldorf, North-Rhine-Westphalia 40225
    Germany

    Active - Recruiting

  • German Heart Center

    Berlin,
    Germany

    Active - Recruiting

  • University Hospital Bonn

    Bonn,
    Germany

    Active - Recruiting

  • Evaggelismos General Hospital

    Athens,
    Greece

    Active - Recruiting

  • University Hospital Padoua

    Padova,
    Italy

    Active - Recruiting

  • Medical University of Warsaw

    Warsaw,
    Poland

    Active - Recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz, Andalucia 11009
    Spain

    Active - Recruiting

  • Hospital Alvaro Cunqueiro Vigo

    Vigo, Galicia 36312
    Spain

    Active - Recruiting

  • Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich

    Zürich,
    Switzerland

    Active - Recruiting

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