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ID05896397

European Study on Safety and Performance of Cooks Custom-Made Endovascular Aortic Stent-Grafts

Led by Cook Research Incorporated · Updated on 2026-06-04

600

Participants Needed

18

Research Sites

204 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to assess the safety and performance of Cooks various custom-made stent-graft devices used for endovascular treatment of complex abdominal aortic aneurysms, thoracoabdominal aortic aneurysms, aortic arch aneurysms, and chronic aortic dissections. The study collects real-world data on the use of these devices to support their ongoing market availability and post-market surveillance as well as further technological development by Cook. Participants will receive treatment using Cooks custom-made endovascular grafts designed for complex aortic diseases. The study is observational and does not involve assigning participants to specific treatment groups but rather monitors patients receiving these devices in usual care settings. During the study, researchers will track treatment success rates at 12 months and safety outcomes within 30 days after treatment. Participants will undergo clinical follow-up visits to monitor outcomes. The study results will contribute to understanding device performance and safety in real-world use. The study will continue until December 2030.

CONDITIONS

Brief Title

European Aortic Data Collection Project

Research Team

G

Gregoire Masliah

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