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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05636527
Acronym
ARCUS
Enrollment
70
Registered
2022-12-05
Start date
2022-11-09
Completion date
2030-07-31
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AAT9

Brief 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.

Interventions

None listed

Sponsors

Endospan Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality30 daysThe 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

MeasureTime frameDescription
Mortality12 monthsAll-cause death events will be counted
Major Adverse Event (MAE)30 days and 12 monthsOccurrence 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
Device failureProcedure, 30 days, 12 monthsDevice 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

Countries

Belgium, Cyprus, France, Germany, Greece, Italy, Netherlands, Poland, Spain, Switzerland

Contacts

Primary ContactNatali Yosef
natali@endospan.com+972507599447
Backup ContactJessica Kleine
j.kleine@endospan.com+16122800208

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026