Study of Safety and Effectiveness of Zenith Fenestrated and Branched Stent Grafts for Complex Abdominal, Thoracoabdominal, and Aortic Arch Aneurysms or Dissections

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-grafts with fenestrations and branches to repair complex abdominal, thoracoabdominal, and aortic arch aneurysms or dissections. These aneurysms cause bulges or weaknesses in major blood vessels, which can lead to serious complications if ruptured. This traditional device feasibility study aims to collect preliminary safety and efficacy information to guide future research and product development. The study involves two groups of patients. The first group includes those with complex abdominal or thoracoabdominal aortic aneurysms treated with either an off-the-shelf Zenith t-Branch or patient-specific stent-grafts featuring 1 to 5 small holes fenestrations or side branches, along with stents in arteries to the liver, intestine, and kidneys. The second group includes patients with aortic arch aneurysms treated with patient-specific stent-grafts containing one to three inner branches or scallops to align with arteries supplying the brain and arms. All grafts are inserted through arteries in the groin or leg using catheters, a procedure known as endovascular repair. Participants will be monitored through various assessments including survival and adverse events at 30 days post-treatment. The study also measures treatment success at 12 months and tracks quality of life over several years. Follow-up includes imaging, physical exams, and questionnaires at multiple time points up to five years. The study will gather detailed clinical data to understand how well these fenestrated and branched stent-grafts work and to ensure patient safety during and after the procedure.

CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft