Evaluation of the NEXUS Aortic Arch Stent Graft System for treating aortic aneurysms

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

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
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Endospan Ltd. (Industry-sponsored)
• Locations: 18 sites (Brussels and 17 other locations)
• Trial ID: NCT05636527 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients who are currently enrolled in other investigational studies that may interfere with this study may not benefit.

Why it matters

Potential benefit: If successful, this study could improve treatment options and outcomes for patients with aortic aneurysms.

How similar studies have performed: Other studies evaluating similar aortic stent graft systems have shown promising results, indicating potential for success in this approach.

Eligibility 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 this trial is running

Brussels and 17 other locations

• 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)
• 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)
• 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, Spain (Recruiting)
• Hospital Alvaro Cunqueiro Vigo — Vigo, Galicia, Spain (Recruiting)
• Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich — Zurich, Switzerland (Recruiting)

Study contacts

• Principal investigator: Hubert Schelzig, MD — University Hospital Duesseldorf, University Clinic for Vascular and Endovascular Surgery
• Study coordinator: Natali Yosef

Conditions AAT9