NCT04252573

Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

Prospective, Multicenter, Non-randomized Study With Consecutive, Eligible Subject Enrollment at Each Site, for the Evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal Aortic Aneurysms.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Endologix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the ChEVAS System for Endovascular Repair of Complex Abdominal Aortic Aneurysms.

Detailed description

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) subjects 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. \*As of October 27, 2021 ChEVAS ONE Study is voluntarily closed to screening and consenting. 13 subjects enrolled in the study will continue to be observed through 5-years.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Chimney Endovascular Aortic Sealing (ChEVAS) System	The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.

Timeline

• Start date: 2020-06-29
• Primary completion: 2022-10-19
• Completion: 2028-03-01
• First posted: 2020-02-05
• Last updated: 2024-12-24
• Results posted: 2024-12-24

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study