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
Condition(s) studied
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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