NCT04471909

NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Endospan Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Dissection
• Aortic Aneurysm
• Intramural Hematoma
• Penetrating Aortic Ulcer

Interventions

Type	Name	Description
DEVICE	NEXUS 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.

Timeline

• Start date: 2020-10-20
• Primary completion: 2025-10-01
• Completion: 2029-10-01
• First posted: 2020-07-15
• Last updated: 2025-10-20

Locations

32 sites across 2 countries: United States, New Zealand

Regulatory

• FDA-regulated device study