NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEndospan Ltd.
About this trial
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.
Eligibility criteria
Qualifiers
Male and female age ≥ 18.
Proximal/ascending native or previously implanted surgical graft landing zone of appropriate length
Proximal/ascending native or previously implanted surgical graft landing zone of appropriate diameter
Distal/descending native landing zone of appropriate length
Disqualifiers
Acute dissection
Lesions that can be safely treated with TEVAR landing in zone 2 (with or w/o LSA vascularization)
Required emergent treatment, e.g., trauma, rupture
Acute vascular injury of the aorta due to trauma
Trial design
Treatments tested in this trial
- NEXUS Aortic Stent Graft System
Treatment groups
110 Participants
are divided into 3 treatment groupsLocations
32New Zealand
Auckland City Hospital1023, AucklandGrafton, New Zealand
United States
Alabama
University of Alabama Birmingham35294, Birmingham United States
California
University of California San Diego Medical Center92037, La Jolla United States
UC Davis Health95817, Sacramento United States
Sponsors and collaborators
Endospan Ltd.
Lead sponsor
Source ClinicalTrials.gov