Actively Recruiting
Further Evaluation of Safety and Performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch 2a Aortic Arch Stent Graft System in an Observational Study
Led by Endospan Ltd. · Updated on 2025-12-04
70
Participants Needed
18
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study aims to collect clinical information on the safety and performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO Aortic Arch Stent Graft System for treating aortic aneurysms. The main questions focus on early mortality, safety outcomes, device failure, and procedural and hospitalization details. Participants are treated according to standard care at their institutions. Participants receive treatment per their institution's standard of care using either the NEXUS Aortic Arch Stent Graft System or the custom-made NEXUS DUO Aortic Arch Stent Graft System. The study includes both prospective and retrospective data collection with two groups based on the device used. Follow-up information is collected for up to five years after treatment. During the study, researchers will gather data on mortality at 30 days and 12 months, major adverse events, device failure, and other safety outcomes. Participants will undergo regular follow-up visits to monitor these outcomes and collect hospitalization and procedural information. The study is designed to observe real-world use of these devices and understand their longer-term safety and performance.
CONDITIONS
Brief 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 6518 years
- Indicated for implant of the NEXUS Aortic Arch System or custom-made NEXUS DUO Aortic Arch System according to current instructions for use
- Already implanted with the NEXUS or NEXUS DUO device since February 2019
- Able and willing to provide informed consent
- Not currently enrolled in another investigational study or registry that interferes with this study, except mandatory or purely observational registries
- Life expectancy exceeds one year according to the investigator
- Not pregnant or planning to become pregnant
- Stable renal function for the NEXUS procedure as judged by the physician
- No co-morbidities or planned surgeries interfering with device implant, such as major cardiac surgery or interventional procedures in the last 90 days, or recent myocardial infarction or stroke
You will not qualify if you...
- Currently enrolled in another investigational study or registry that directly interferes with this study, except mandatory or purely observational registries
- Pregnant or planning to become pregnant
- Unstable renal function for the NEXUS procedure as judged by the physician
- Co-morbidities or planned surgeries interfering with device implant, including major cardiac surgery or interventional procedures in the last 90 days, myocardial infarction, or stroke in the last 90 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants who have already received the NEXUS or NEXUS DUO device are observed to evaluate safety and device performance over time.
Follow-up visits at 30 days and 12 months after device implantation
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
J
Jessica Kleine
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
Frequently Asked Questions
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