Study of Zenith t-Branch and Terumo Arch Branch Endovascular Grafts for Treating Aortic Aneurysms

What this Trial Is About

Researchers are evaluating the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch endograft for treating aortic aneurysms, including thoracoabdominal and aortic arch aneurysms. This study aims to collect information on these devices use in patients with specific aortic pathologies not treatable by conventional methods. The trial includes two groups one receiving the Zenith t-Branch device and another receiving the Terumo Arch Branch device, both investigational and designed for different aortic regions. Participants in the Zenith t-Branch cohort receive an endovascular graft designed with branches to maintain blood flow to visceral arteries, with some custom-made versions for unique vessel conditions. The Terumo Arch Branch cohort receives a custom-made endograft based on the Relay thoracic stent graft platform, intended for placement in the ascending aorta and arch, constructed to provide stability and attachment to the aortic wall. Both devices are implanted through endovascular techniques. During the study, participants undergo monitoring for early mortality and stroke within 30 days after device implantation. Further assessments include rates of neurological complications and branch vessel patency up to five years post-implant. Researchers collect detailed follow-up data to evaluate safety and device performance. Participation involves regular clinical evaluations and imaging to track outcomes throughout the study duration, which extends until January 2032.

Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms