NCT02365454

NEXUS™ Aortic Arch Stent Graft System First In Man Study

Feasibility Clinical Study to Evaluate the Safety and Performance of the NEXUS™ Aortic Arch Stent Graft System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Endospan Ltd. · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The purpose of the study is to evaluate the safety and performance of the Nexus™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic pathologies requiring landing in the Aortic Arch (zone 0, zone 1, zone 2). The Nexus™ Aortic Arch Stent Graft System is indicated for the endovascular treatment of thoracic aortic pathologies involving the aortic arch (such as aneurisms and dissections). The Nexus™ is intended to exclude the lesion from the blood circulation in patients diagnosed with thoracic aortic pathology and who have appropriate anatomy to accommodate the Nexus™ system in an endovascular procedure. The primary objectives of the study are to evaluate the safety and performance of the Nexus™ Aortic Arch Aneurysm Stent Graft System.

Conditions

• Thoracic Aortic Arch Disease
• Thoracic Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Stent Graft Placement (Nexus)	The Nexus stent graft is introduced through a groin to the diseased location at the Aortic Arch. Depending on the patients anatomy and other medical considerations the physician may decide that blood flow to the sub-clavian artery and possibly also to the left carotid artery is required to be maintained via "surgical bypass grafting", either immediately, or a few days, before the implantation. In addition to the incision for introducing the investigational stent graft, two smaller access sites are required, one at the groin on the opposite side and on into the Right Arm to the Brachial Artery. This endovascular procedure will likely require full anesthesia. The entire procedure is assisted by an angiography imaging system.

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-11-01
• Completion: 2023-06-01
• First posted: 2015-02-19
• Last updated: 2023-09-21

Locations

4 sites across 3 countries: Czechia, Italy, Switzerland