NCT01654133

Evaluation of Visceral Function Following Endovascular Aortic Aneurysm Repair Using Branched Stent- Grafts

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 770 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate visceral function, after endovascular repair of thoracoabdominal aneurysms or ascending/aortic arch aneurysms.

Detailed description

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.

Conditions

• Aortic Aneurysm, Abdominal
• Ascending Aorta Aneurysm
• Aortic Arch Aneurysm

Interventions

Type	Name	Description
DEVICE	Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using branched stent graft	Repair of thoracoabdominal aortic aneurysms
DEVICE	Endovascular repair of ascending/arch aortic aneurysm using branched stent graft	Repair of ascending/arch aortic aneurysms

Timeline

• Start date: 2012-07-01
• Primary completion: 2035-08-01
• Completion: 2035-08-01
• First posted: 2012-07-31
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States