Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT01654133
Brief 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.
Study:
NCT01654133
Study Brief:
Protocol Section:
NCT01654133