Actively Recruiting
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
Led by Endospan Ltd. · Updated on 2025-12-04
70
Participants Needed
18
Research Sites
398 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female age 653018 years
- Indicated for implant of the NEXUS Aortic Arch System as per current Instructions for Use (IFU)
- Indicated for implant of the custom-made NEXUS DUO Aortic Arch System as per current IFU
- Already implanted with the NEXUS or NEXUS DUO after February 2019 according to relevant IFU
- Able and willing to provide informed consent to participate in the study
- Not currently enrolled in another investigational study or registry that would interfere with this study, except mandatory government registries or purely observational registries
- In the investigator's opinion, life expectancy exceeds one year
- Not pregnant or planning to become pregnant
- In physician's opinion, renal function is stable for the NEXUS procedure
- Investigator's opinion that no co-morbidities or planned surgeries will interfere with device implant, such as major cardiac surgery or interventional procedure in the last 90 days, or myocardial infarction or cerebral vascular accident in the last 90 days
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 18 locations
1
Cliniques universitaires Saint Luc
Brussels, Belgium, 1200
Actively Recruiting
2
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
3
Aretaieio Hospital
Nicosia, Cyprus, Cyprus, 2024
Actively Recruiting
4
APHP Henri Mondor
Paris, France
Actively Recruiting
5
Hôpital Européen Georges Pompidou
Paris, France
Actively Recruiting
6
Immanuel Klinikum Brandenburg, Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, Germany, 16321
Actively Recruiting
7
University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
8
German Heart Center
Berlin, Germany
Actively Recruiting
9
University Hospital Bonn
Bonn, Germany
Actively Recruiting
10
Evaggelismos General Hospital
Athens, Greece
Actively Recruiting
11
Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia
Brescia, Italy, 25123
Not Yet Recruiting
12
University Hospital Padoua
Padova, Italy
Actively Recruiting
13
Stichting Amsterdam UMC,
Amsterdam, Netherlands, 1081
Actively Recruiting
14
University Medical Center Groningen
Groningen, Netherlands
Not Yet Recruiting
15
Medical University of Warsaw
Warsaw, Poland
Actively Recruiting
16
Hospital Universitario Puerta del Mar
Cadiz, Andalusia, Spain, 11009
Actively Recruiting
17
Hospital Alvaro Cunqueiro Vigo
Vigo, Galicia, Spain, 36312
Actively Recruiting
18
Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich
Zurich, Switzerland
Actively Recruiting
Research Team
N
Natali Yosef
CONTACT
J
Jessica Kleine
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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