Visceral (Kidney and Abdominal Organ) Function After Fenestrated and Branched Endovascular Aneurysm Repair (FEVAR/BEVAR) of Thoracoabdominal Aortic Aneurysms
|ClinicalTrials.gov Identifier: NCT01654133|
Recruitment Status : Enrolling by invitation
First Posted : July 31, 2012
Last Update Posted : April 19, 2017
|Condition or disease||Intervention/treatment|
|Aortic Aneurysm, Abdominal||Device: Endovascular repair of TAAA using branched stent graft|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Visceral Function Following Fenestrated Endovascular Aortic Aneurysm Repair (FEVAR) Using Branch Stent-Grafts|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: enodvascular repair TAAA
Endovascular repair of TAAA using Branched stent grafts
Device: Endovascular repair of TAAA using branched stent graft
Repair of thoracoabdominal aortic aneurysms
Other Name: Endovascular repair of thoracoabdominal aortic aneurysm
- Change from baseline in renal function over time (up to two years) after endovascular aortic aneurysm repair various custom stent grafts [ Time Frame: Pre-procedure and 1, 6, 12, 18, and 24 months post procedure ]Visceral function after endovascular repair of pararenal aneurysms using various custom stent grafts. Specifically, the device orientation and configuration will be evaluated with respect to renal function over time. Critical data concerning each branched vessel from radiological studies coupled with hemodynamic data obtained from renal artery duplex, changes in renal volume, eGFR, and flow characteristics at 1, 6, 12, 18 and 24 months post procedure may make it possible to determine changes in renal function.
- Time to morbidity [ Time Frame: 30 days and 1 & 2 years post procedure ]Morbidity at 30 days, 1 & 2 years post procedure
- Time to mortality [ Time Frame: 30 days and 1 & 2 years post procedure ]Mortality at 30 days, 1 & 2 years post procedure.
- Time to loss of stent graft integrity [ Time Frame: 30 days and 1 & 2 years post procedure ]Evidence on contrast CTA of loss of stent graft integrity at 30 days, and one and two years post procedure.
- Time to migration [ Time Frame: 30 days and 1 & 2 years post procedure ]Evidence of stent graft migration on abdominal x-rays at 30 days and 1 & 2 years.
- Endoleak [ Time Frame: 30 days and 1 & 2 years post procedure ]Evidence of Endoleak on contrast CTA of abdomen 30 days and 1 & 2 years post procedure.
- Branch vessel Events [ Time Frame: 30 days and 1 & 2 years post procedure ]Evidence of branch vessel events on contrast CTA and renal duplex 30 days, and 1 & 2 years post procedure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654133
|United States, North Carolina|
|UNC Heart and Vascular|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Mark A Farber, MD||University of North Carolina, Chapel Hill, NC 27599|