An observational study in AAT9, sponsored by Endospan Ltd.. Recruiting at 18 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by Endospan Ltd. · Observational
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:
Endospan Ltd. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Mortality
All-cause death events will be counted
Time frame: 12 months
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
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
Started Nov 2022 (actual). Primary completion is estimated for Mar 2027, 52 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Endospan Ltd.