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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.
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Valley Vascular Consultants
Huntsville, Alabama, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
St Vincent Medical Group
Indianapolis, Indiana, United States
University of Missouri
Columbia, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Providence Portland
Portland, Oregon, United States
Start Date
June 29, 2020
Primary Completion Date
October 19, 2022
Completion Date
March 1, 2028
Last Updated
December 24, 2024
13
ACTUAL participants
Chimney Endovascular Aortic Sealing (ChEVAS) System
DEVICE
Lead Sponsor
Endologix
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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