Using Custom and Physician-Modified Devices to Repair Complex Aortic Aneurysms Including Aortic Arch and Thoracoabdominal Aneurysms

What this Trial Is About

Researchers are evaluating the safety and effectiveness of custom-made devices, Zenith t-Branch devices, and physician-modified FDA-approved endovascular grafts for treating patients with complex aortic aneurysms, including abdominal, aortoiliac, thoracoabdominal, and aortic arch aneurysms. This study includes patients whose anatomy is unsuitable for currently marketed grafts in the United States, those who cannot wait for commercial device manufacturing, and those at high risk for open surgical repair. The study also includes patients with connective tissue diseases such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndromes. The treatments involve custom-made fenestrated or branched stent grafts that are tailored to the patients anatomy by adding small holes fenestrations to allow blood flow to critical organs like the kidneys, liver, and intestines. Depending on the patients urgency and anatomy, repair is done with a custom-made device, a Zenith t-Branch device, or a physician-modified device. The device is inserted through small incisions in the groin or upper arm, and stents are placed through the graft fenestrations into affected blood vessels to maintain blood flow. Participants will be monitored over time to assess the success of the treatment and any major adverse events within 30 days of the procedure. Follow-up will continue for five years to evaluate long-term outcomes. Researchers will use imaging and clinical assessments to track treatment effectiveness, focusing on the proportion of patients achieving treatment success 12 months after the procedure. Safety and adverse events will also be closely monitored throughout the study.

Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices