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NCT Number: NCT05636527

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

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.

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Key information

Conditions

AAT9

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques universitaires Saint Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Male and female age ≥18 years
  • The subject is indicated for implant of the NEXUS Aortic Arch System in accordance with the current IFU, or
  • The subject is indicated for implant of the custom-made NEXUS DUO Aortic Arch System in accordance with the current IFU, or
  • The subject has been already implanted, after February 2019, with the NEXUS or the NEXUS DUO according to the relevant IFU
  • The subject is able and willing to provide informed consent to participate in the study.
  • 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.
  • In the opinion of the Investigator, life expectancy exceeds one year
  • The subject is not pregnant or planning to become pregnant.
  • In the physician's opinion, subject's renal function is stable for the NEXUS procedure.
  • 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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 30 days

    The primary outcome in this study is early mortality, defined as lesion related death or any death that occurs within 30-days post-procedure or within initial hospitalization following the index procedure (whichever occurs last), unless there is evidence of accidental or self-inflicted death

Secondary outcomes

  1. Mortality

    Time frame: 12 months

    All-cause death events will be counted

  2. Major Adverse Event (MAE)

    Time frame: 30 days and 12 months

    Occurrence of at least one of the following MAEs at 30 days and 1 year post NEXUS implantation

    • Disabling Stroke
    • Permanent Paralysis/Paraplegia
    • Renal failure
    • Aortic rupture
    • Development of new dissections in the thoracic aorta or brachiocephalic artery

  3. Device failure

    Time frame: Procedure, 30 days, 12 months

    Device Failure will be assessed via the following outcomes:

    • Peri-operative device failure
    • Device occlusion
    • Surgical conversion
    • Re-Intervention to treat migration,
    • Re-Intervention to treat stenosis or occlusion,
    • Re-Intervention to treat type Ia, Ib, III, IV endoleaks
    • Re-Intervention for loss of device integrity

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Kleine

CONTACT

[email protected]

+16122800208

Natali Yosef

CONTACT

[email protected]

+972507599447

Sponsors and collaborators

Lead sponsor

Endospan Ltd.

Industry

Registry information

Official study title

A Non-Randomized, Prospective or Retrospective, Open-Label, Multi-Center, Observational Clinical Study With Two Arms to Further Evaluate Safety and Performance of the NEXUS® Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch™ Aortic Arch Stent Graft System

Acronym: ARCUS

Important dates

Study start
2022
Primary completion
2027
Study completion
2030
First posted
Dec 5, 2022
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.