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Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

Recruiting
18 years and older
All
Phase N/A

This is a prospective multicenter study with consecutive eligible subject enrollment at each site. Enrollment will include up to 150 subjects (120 ChEVAS subjects and up to 30 infrarenal roll-in subjects). The ChEVAS study will evaluate the safety and effectiveness outcomes following appropriate government and ethics committee/IRB requirements and guidelines.

All enrolled (ChEVAS and Infrarenal) patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30-days, 6-months, and annually to 5-years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

Study details
    1 Paravisceral Abdominal Aortic Aneurysm
    2 Juxtarenal Abdominal Aortic Aneurysm
    3 Pararenal Abdominal Aortic Aneurysm
    4 Complex Abdominal Aortic Aneurysms

NCT04252573

Endologix

19 February 2024

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