NCT03208504

The Single Branch NEXUS™ Clinical Study

A Multi-center Prospective Open-Label Non-Randomized Clinical Study to Evaluate the Safety and Performance of the Single Branch Nexus™ Aortic Arch Stent Graft System.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Endospan Ltd. · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Subjects will be followed-up for five years.

Detailed description

The purpose of the study is to evaluate the safety and performance of the Single Branch Nexus™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic pathologies requiring landing in the Aortic Arch (zone 0, zone 1, zone2). The investigational device is the Single Branch Nexus™ Aortic Arch Stent Graft System and its designated Delivery System. Subject population: ten (10) subjects diagnosed with thoracic aortic disease involving the aortic arch, and who have appropriate anatomy to accommodate the Single Branch Nexus™ delivery system in an endovascular procedure. The study will be conducted in 2 clinical sites in Germany.

Conditions

• Thoracic Aortic Diseases

Interventions

Type	Name	Description
DEVICE	Nexus™ Aortic Arch Stent graft	surgical implantation of Nexus™ Aortic Arch Stent graft

Timeline

• Start date: 2017-11-27
• Primary completion: 2018-02-16
• Completion: 2023-01-20
• First posted: 2017-07-05
• Last updated: 2023-02-22

Locations

1 site across 1 country: Germany