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

ConditionAAT9
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEndospan Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 2 trial groups
Group A: NEXUS Aortic Arch Stent Graft System
Group B: Custom-made NEXUS Multibranch™ Aortic Arch Stent Graft System

Trial outcomes

Primary outcomes

1

Mortality

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

Time frame
30 days

Secondary outcomes

1

Mortality

All-cause death events will be counted

Time frame
12 months
2

Major Adverse Event (MAE)

Occurrence of at least one of the following MAEs at 30 days and 1 year post NEXUS implantation * Disabling Stroke * Permanent Paralysis/Paraplegia * Renal failure * Aortic rupture * Development of new dissections in the thoracic aorta or brachiocephalic artery

Time frame
30 days and 12 months
3

Device failure

Device Failure will be assessed via the following outcomes: * Peri-operative device failure * Device occlusion * Surgical conversion * Re-Intervention to treat migration, * Re-Intervention to treat stenosis or occlusion, * Re-Intervention to treat type Ia, Ib, III, IV endoleaks * Re-Intervention for loss of device integrity

Time frame
Procedure, 30 days, 12 months

Other outcomes

Sponsors and contacts

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