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