A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch
Endospan Ltd.
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and female age ≥ 18. 2. Proximal/ascending native or previously implanted surgical graft landing zone of appropriate length 3. Proximal/ascending native or previously implanted surgical graft landing zone of appropriate diameter 4. Distal/descending native landing zone of appropriate length 5. Distal/descending native landing zone of appropriate diameter 6. Brachiocephalic trunk native landing zone of appropriate length 7. Brachiocephalic trunk native landing zone of appropriate diameter 8. Appropriate take off angle between the Brachiocephalic Artery and the Aorti…
Interventions
- DeviceNEXUS Aortic Stent Graft System
Arch 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.
Locations (32)
- University of Alabama BirminghamBirmingham, Alabama
- University of California San Diego Medical CenterLa Jolla, California
- UC Davis HealthSacramento, California
- Stanford University School of MedicineStanford, California
- University of ColoradoAurora, Colorado
- Hartford HospitalHartford, Connecticut