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 groupsSponsors and collaborators
Source ClinicalTrials.gov