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…