Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-04 @ 5:21 AM
Study NCT ID:
NCT03208504
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2017-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Single Branch NEXUS™ Clinical Study
Sponsor:
Endospan Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NexusSB
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: