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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
NEXUS Aortic Stent Graft System
DeviceArch Stent Graft, whose cranial narrow end is intended to be deployed into the Brachiocephalic artery and whose distal end is intended to be deployed into the Descending Thoracic Aorta. Ascending Stent Graft intended to be deployed in the Ascending Aorta. OPTIONAL: Descending Extension can be used in case the aortic lesion elongates further distally and out of the covered length offered by the Arch Stent Graft. Multiple Descending Extensions can be used if needed to cover the entire length of the lesion.
Treatment groups
110 Participants
are divided into 3 treatment groupsGroup A: Chronic Dissection (arm closed to enrollment)Experimental treatment 1 intervention
Group B: Penetrating Aortic Ulcer and/or Intramural HematomaExperimental treatment 1 intervention
Group C: Aneurysm (arm closed to enrollment)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device Technical Failure
* Failure to accurately deliver, track and deploy all required endovascular device components at the intended implantation site and failure to retrieve the device delivery systems without the need for unplanned additional procedures * Device occlusion * Failed exclusion of primary entry tear * Additional unanticipated surgical or interventional procedure related to the device or procedure, to prevent life-threatening or permanent disabling event.
Time frame
30 Days2
Clinical Failure
Subjects experiencing early mortality or at least one of the following MAEs through 30-Day of Phase 1 Procedure and 30-Day of Index Procedure: Disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, development of new dissections in the thoracic aorta or brachiocephalic artery.
Time frame
30 DaysSponsors and contacts
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Source ClinicalTrials.gov