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Recruiting Observational

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

NCT05636527 · tracked via the Priya Life Science Italy tracker
Sponsor
Endospan Ltd
Phase
Observational
Started
2022-11-09
Last updated
2025-12-04

Condition(s) studied

AAT9

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Mortality — 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

Trial sites (18)

FacilityCityRegionStatus
Cliniques universitaires Saint Luc Brussels Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
Aretaieio Hospital Nicosia Cyprus Recruiting
APHP Henri Mondor Paris France Recruiting
Hôpital Européen Georges Pompidou Paris France Recruiting
Immanuel Klinikum Brandenburg, Herzzentrum Brandenburg Bernau bei Berlin Brandenburg Recruiting
University Hospital Duesseldorf Düsseldorf North Rhine-Westphalia Recruiting
German Heart Center Berlin Germany Recruiting
University Hospital Bonn Bonn Germany Recruiting
Evaggelismos General Hospital Athens Greece Recruiting
Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia Brescia Italy Not Yet Recruiting
University Hospital Padoua Padova Italy Recruiting
Stichting Amsterdam UMC, Amsterdam Netherlands Recruiting
University Medical Center Groningen Groningen Netherlands Not Yet Recruiting
Medical University of Warsaw Warsaw Poland Recruiting
Hospital Universitario Puerta del Mar Cadiz Andalusia Recruiting
Hospital Alvaro Cunqueiro Vigo Vigo Galicia Recruiting
Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich Zurich Switzerland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05636527 on ClinicalTrials.gov ↗ ← All trials in Italy