Evaluation of the NEXUS Aortic Arch Stent Graft System for treating aortic aneurysms
Official 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
Run by Endospan Ltd. · NCT05636527 · Data updated 2026-11-12
This study is testing how safe and effective the NEXUS Aortic Arch Stent Graft System is for people with aortic aneurysms over a follow-up period of up to five years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Endospan Ltd. Industry-sponsored |
| Locations | 18 sites (Brussels and 17 other locations) |
| Status | Recruiting |
| Started | November 9, 2022 |
| Main results expected | March 2027 |
| Study ends | July 2030 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT05636527 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who are indicated for the NEXUS Aortic Arch System or have previously received it since February 2019.
✕Probably not a fit
Patients who are currently enrolled in other investigational studies that may interfere with this study may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to gather clinical data on the safety and performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System in patients with aortic aneurysms. Participants will be treated according to standard care protocols, and the study will monitor early mortality, safety outcomes, device failures, and hospitalization details over a follow-up period of up to five years. The goal is to assess how well these devices function in real-world clinical settings.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for patients with aortic aneurysms.
How similar studies have gone: Other studies evaluating similar aortic stent graft systems have shown promising results, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Cliniques universitaires Saint Luc
Brussels, Belgium Recruiting -
UZ Leuven
Leuven, Belgium Recruiting -
Aretaieio Hospital
Nicosia, Cyprus, Cyprus Recruiting -
APHP Henri Mondor
Paris, France Recruiting -
Hôpital Européen Georges Pompidou
Paris, France Recruiting -
Immanuel Klinikum Brandenburg, Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, Germany Recruiting
Show 12 more locations
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University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, Germany Recruiting -
German Heart Center
Berlin, Germany Recruiting -
University Hospital Bonn
Bonn, Germany Recruiting -
Evaggelismos General Hospital
Athens, Greece Recruiting -
University Hospital Padoua
Padova, Italy Recruiting -
Stichting Amsterdam UMC,
Amsterdam, Netherlands Recruiting -
Medical University of Warsaw
Warsaw, Poland Recruiting -
Hospital Universitario Puerta del Mar
Cadiz, Andalusia, Spain Recruiting -
Hospital Alvaro Cunqueiro Vigo
Vigo, Galicia, Spain Recruiting -
Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich
Zurich, Switzerland Recruiting -
Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia
Brescia, Italy Not yet recruiting -
University Medical Center Groningen
Groningen, Netherlands Not yet recruiting
Study contacts
- Principal investigator: Hubert Schelzig, MD — University Hospital Duesseldorf, University Clinic for Vascular and Endovascular Surgery
- Study coordinator: Natali Yosef
- Email: natali@endospan.com
- Phone: +972507599447
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.