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

Endospan Ltd.18 sites in 10 countries70 target enrollmentNovember 9, 2022

ConditionsAAT9

Overview

Phase: N/A
Intervention: Not specified
Conditions: AAT9
Sponsor: Endospan Ltd.
Enrollment: 70
Locations: 18
Primary Endpoint: Mortality
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 9, 2022

End Date

July 1, 2030

Last Updated

4 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Endospan Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Mortality

Time Frame: 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