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 DUO™ Aortic Arch Stent Graft System

Status: Recruiting
Location: See all (11) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Male and female age ≥18 years

⁃ The subject is indicated for implant of the NEXUS Aortic Arch System in accordance with the current IFU, or

⁃ The subject is indicated for implant of the custom-made NEXUS DUO Aortic Arch System in accordance with the current IFU, or

⁃ The subject has been already implanted, after February 2019, with the NEXUS or the NEXUS DUO according to the relevant IFU

⁃ The subject is able and willing to provide informed consent to participate in the study.

⁃ 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.

⁃ In the opinion of the Investigator, life expectancy exceeds one year

⁃ The subject is not pregnant or planning to become pregnant.

⁃ In the physician's opinion, subject's renal function is stable for the NEXUS procedure.

• 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

Locations
Other Locations
France
APHP Henri Mondor
RECRUITING
Paris
Hôpital Européen Georges Pompidou
RECRUITING
Paris
Germany
German Heart Center
RECRUITING
Berlin
University Hospital Bonn
RECRUITING
Bonn
University Hospital Duesseldorf
RECRUITING
Düsseldorf
Greece
Evaggelismos General Hospital
RECRUITING
Athens
Italy
University Hospital Padoua
RECRUITING
Padua
Poland
Medical University of Warsaw
RECRUITING
Warsaw
Spain
Hospital Universitario Puerta del Mar
RECRUITING
Cadiz
Hospital Alvaro Cunqueiro Vigo
RECRUITING
Vigo
Switzerland
Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich
RECRUITING
Zurich
Contact Information
Primary
Natali Yosef
natali@endospan.com
+972507599447
Backup
Jessica Kleine
j.kleine@endospan.com
+16122800208
Time Frame
Start Date: 2022-11-09
Estimated Completion Date: 2030-07
Participants
Target number of participants: 60
Treatments
NEXUS Aortic Arch Stent Graft System
Custom-made NEXUS DUO™ Aortic Arch Stent Graft System
Related Therapeutic Areas
Sponsors
Leads: Endospan Ltd.

This content was sourced from clinicaltrials.gov