Clinical trial NCT05636527: Further Evaluation of Safety and Performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AAT9
Lead sponsor: Endospan Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with a thoracic aortic aneurysm or chronic dissection extending to or involving the aortic arch and who are considered candidates for the endovascular repair.

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.


Eligibility criteria: 1. Male and female age ≥18 years
2. The subject is indicated for implant of the NEXUS Aortic Arch System in accordance with the current IFU, or
3. The subject is indicated for implant of the custom-made NEXUS DUO Aortic Arch System in accordance with the current IFU, or
4. The subject has been already implanted, after February 2019, with the NEXUS or the NEXUS DUO according to the relevant IFU
5. The subject is able and willing to provide informed consent to participate in the study.
6. 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.
7. In the opinion of the Investigator, life expectancy exceeds one year
8. The subject is not pregnant or planning to become pregnant.
9. In the physician's opinion, subject's renal function is stable for the NEXUS procedure.
10. 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

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 12 months
measure: Major Adverse Event (MAE)
timeFrame: 30 days and 12 months
measure: Device failure
timeFrame: Procedure, 30 days, 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP Henri Mondor
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Duesseldorf
country: Germany
facility: University Hospital Duesseldorf
state: North-Rhine-Westphalia
city: Berlin
country: Germany
facility: German Heart Center
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Athens
country: Greece
facility: Evaggelismos General Hospital
city: Padova
country: Italy
facility: University Hospital Padoua
city: Warsaw
country: Poland
facility: Medical University of Warsaw
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
state: Andalucia
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro Vigo
state: Galicia
city: Zürich
country: Switzerland
facility: Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich
Study officials:
affiliation: University Hospital Duesseldorf, University Clinic for Vascular and Endovascular Surgery
name: Hubert Schelzig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua
name: Augusto D'Onofrio
role: PRINCIPAL_INVESTIGATOR
References: