Study of Three Custom Endografts for Treating Complex Aortic Conditions including Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch Pathologies

What this Trial Is About

Researchers are evaluating the safety and effectiveness of three investigational devicesthe Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endograftsin treating complex aortic conditions such as juxtarenal, suprarenal, thoracoabdominal, and aortic arch pathologies that involve at least one brachiocephalic artery or visceral vessels. These devices provide a customized endovascular approach aimed at addressing conditions not treatable with commercially available devices and may reduce hospital stays and complications. Participants will receive one of the three investigational devices based on their specific condition. The Cook Custom Aortic Endograft is designed with up to five fenestrations andor branches to seal and fix the device around affected areas. The Zenith t-Branch Endovascular Graft features four branches connected to key arteries with self-expanding stents. Surgeon-Modified Endografts are created during surgery by adapting existing devices to fit the patients anatomy. Before treatment, participants undergo exams, blood tests, CT scans, X-rays, angiography, and other assessments depending on the aortic pathology. Participants will be followed for five years with regular clinical exams, imaging, neurological assessments, and blood tests to monitor device performance and safety. Researchers will track major adverse events within 30 days post-procedure and monitor mortality rates, pulmonary complications, neurologic morbidity, device integrity, and need for further interventions at multiple time points up to five years. This comprehensive follow-up helps assess the long-term effects and success of these investigational devices in treating complex aortic diseases.

Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies