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.
Study Type
OBSERVATIONAL
Enrollment
70
Cliniques universitaires Saint Luc
Brussels, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGAretaieio Hospital
Nicosia, Cyprus, Cyprus
RECRUITINGAPHP Henri Mondor
Paris, France
RECRUITINGHôpital Européen Georges Pompidou
Paris, France
RECRUITINGImmanuel Klinikum Brandenburg, Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, Germany
RECRUITINGUniversity Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, Germany
RECRUITINGGerman Heart Center
Berlin, Germany
RECRUITINGUniversity Hospital Bonn
Bonn, Germany
RECRUITINGEvaggelismos General Hospital
Athens, Greece
RECRUITING...and 8 more locations
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
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