Study to Assess Safety and Effectiveness of NEXUS Aortic Arch Stent Graft System for Treating Thoracic Aortic Lesions Involving the Aortic Arch

What this Trial Is About

Researchers are evaluating the NEXUS Aortic Arch Stent Graft System in adults with thoracic aortic lesions involving the aortic arch and ascending aorta. This prospective, non-randomized, multi-center clinical investigation aims to assess the safety and effectiveness of this device for treating conditions such as aortic dissection, aneurysm, intramural hematoma, and penetrating aortic ulcer. The study focuses on patients with specific anatomical landing zones in the aortic arch and brachiocephalic trunk. The study uses the NEXUS Aortic Stent Graft System, which includes an arch stent graft deployed into the brachiocephalic artery and descending thoracic aorta, and an ascending stent graft for the ascending aorta. An optional descending extension can cover longer lesions if needed. Participants receive the device through endovascular repair with access via femoral, iliac, or brachialaxillary arteries. The study includes multiple arms targeting different lesion types, some closed to enrollment. Participants will undergo device implantation and follow-up visits to monitor technical and clinical outcomes at 30 days, including device technical failure and clinical failure. Assessments include imaging to evaluate vascular access and lesion coverage, along with safety monitoring. Participants must comply with study procedures and return for follow-up as scheduled. The study does not specify a maximum age and excludes certain acute or emergent conditions and prior treatments in the target area.

NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness