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The purpose of this study is to evaluate visceral function, after endovascular repair of thoracoabdominal aneurysms or ascending/aortic arch aneurysms.
This study will evaluate the effect of endovascular repair of thoracoabdominal aortic aneurysms (Types I-IV) on visceral function or aortic arch aneurysms using custom manufactured and off the shelf stent grafts. Specifically, the device orientation and configuration will be evaluated with respect to renal function. Since detailed CT scan imaging will be performed prior to and after endovascular repair, critical data concerning each branched vessel length, tangential orientation from the aorta, angle of incidence, and diameter can be determined. This information can then be coupled with hemodynamic data obtained from duplex ultrasonography as well as changes in renal volume, estimated glomerular filtration rate (eGFR), and flow characteristics over time. By analyzing the data in this fashion, it may be possible to determine changes in hemodynamics and/or physiologic conditions with respect to branched stent-graft design characteristics. These data may be utilized to enhance current device design and improve patient outcomes. The FDA has approved the use of commercially available devices to be used in conjunction with the investigational device if the Investigator deems this necessary.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UNC Heart and Vascular
Chapel Hill, North Carolina, United States
Start Date
July 1, 2012
Primary Completion Date
August 1, 2035
Completion Date
August 1, 2035
Last Updated
March 17, 2025
645
ESTIMATED participants
Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using branched stent graft
DEVICE
Endovascular repair of ascending/arch aortic aneurysm using branched stent graft
DEVICE
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborators
NCT02089607
NCT05896397
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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