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

NCT01654133 | Enrolling By Invitation DMC

• 1 other identifier: 12-0644
• Study Type: interventional
• Target: 770
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aortic Aneurysm, Abdominal; Ascending Aorta Aneurysm; Aortic Arch Aneurysm

Keywords

Aortic Aneurysm, abdominal; Ascending Aorta Aneurysm; Aortic Arch Aneurysm

Outcome Measures

Primary Outcomes (1)

• Change from baseline in renal function over time (up to two years) after endovascular aortic aneurysm repair various custom stent grafts

  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.

  Pre-procedure and 1, 6, 12, 18, and 24 months post procedure

Secondary Outcomes (6)

• Time to morbidity

  30 days and 1 & 2 years post procedure

• Time to mortality

  30 days and 1 & 2 years post procedure

• Time to loss of stent graft integrity

  30 days and 1 & 2 years post procedure

• Time to migration

  30 days and 1 & 2 years post procedure

• Endoleak

  30 days and 1 & 2 years post procedure

Study Arms (2)

Endovascular TAAA Repair

EXPERIMENTAL

Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using Branched stent grafts

Device: Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using branched stent graft

Endovascular Ascending/Aortic Arch Branch Repair

EXPERIMENTAL

Endovascular repair of aortic ascending/arch aneurysm using branched stent grafts

Device: Endovascular repair of ascending/arch aortic aneurysm using branched stent graft

Interventions

Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using branched stent graft DEVICE

Repair of thoracoabdominal aortic aneurysms

Also known as: Endovascular repair of thoracoabdominal aortic aneurysm

Endovascular TAAA Repair

Endovascular repair of ascending/arch aortic aneurysm using branched stent graft DEVICE

Repair of ascending/arch aortic aneurysms

Also known as: Endovascular repair of ascending/ arch aortic aneurysm

Endovascular Ascending/Aortic Arch Branch Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be included in the study if the patient has at least one of the following and has aortic anatomy appropriate for treatment with the Zenith® p-Branch™, Zenith® t-Branch, or Physician Specified TAAA Endovascular Graft (Custom Manufactured Devices).
• Aortic Aneurysm Diameter
• a. TAAA (Type I - IV) (including pararenal subtypes) with orthogonal aortic diameter greater than or equal to 5 cm or b. greater than two times the normal aortic diameter
• Rapid aortic enlargement (\> than or equal to 5mm in 1 year)
• Presence of a saccular aneurysm at risk for rupture based on investigators evaluation
• Iliac artery aneurysm ˃2.2 cm may be treated with the Zenith® Branch Endovascular Graft-Iliac Bifurcation when the iliac artery aneurysm is associated with the qualifying thoracoabdominal aneurysm treated in this study

You may not qualify if:

• Patients must be excluded from the study if any of the following conditions are true:
• Less than 18 years of age
• Unwilling to comply with the follow-up schedule
• Inability or refusal to give informed consent
• Patients must be excluded from the study if any of the following conditions are true:
• \) Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold 2) History of anaphylactic reaction to contrast material that cannot be adequately premedicated 3) Leaking, ruptured aneurysm associated with hypotension 4) Uncorrectable coagulopathy
• Patients must be excluded from the study if any of the following conditions are true:
• Inadequate femoral/iliac access compatible with the required delivery systems;
• Does not have a non-aneurysmal aortic segment proximal to the aneurysm with:
• a. A length of at least 4 mm, i.e. at least 4 mm circumferential wall contact around the limits of scallop b. A diameter measured outer wall to outer wall of no greater than 31mm and no less than 21 mm; c. An angle less than 60 degrees relative to the centerline of the aneurysm; d. An angle less than 45 degrees relative to the supraceliac aorta.
• Does not have visceral vessel anatomy compatible with Zenith® p-Branch™, specifically:
• a. Renal vessel origins as measured relative to the superior mesenteric artery (SMA) compatible with the renal fenestration, i.e. Both renal vessel origins within 7.5mm of the corresponding renal fenestrations; b. Celiac vessel origin as measured relative to the superior mesenteric artery (SMA) compatible with the celiac scallop.
• A proximal seal site with unsuitable thrombus/atheroma
• Does not have iliac artery fixation sites and anatomy consistent with:
• Common iliac artery fixation site diameter, measured outer wall to outer wall on a sectional image (CT) \<8.0 mm (prior to deployment)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• UNC Hospitals: collaborator
• Cook Group Incorporated: collaborator

Study Sites (1)

UNC Heart and Vascular

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (4)

• Mesnard T, Huang Y, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Parodi FE, Gasper WJ, Beck AW, Sweet MP, Zetterval SL, Lee A, Oderich GS; United States Aortic Research Consortium. Multicenter Prospective Evaluation of Patient Radiation Exposure During Fenestrated-Branched Endovascular Aortic Repair: A Ten-year Experience. Ann Surg. 2025 Feb 18. doi: 10.1097/SLA.0000000000006676. Online ahead of print.

  PMID: 39963789 DERIVED

• Oderich GS, Huang Y, Harmsen WS, Tenorio ER, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Gasper WJ, Beck AW, Sweet MP, Lee WA; United States Aortic Research Consortium. Early and Late Aortic-Related Mortality and Rupture After Fenestrated-Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysms: A Prospective Multicenter Cohort Study. Circulation. 2024 Oct 22;150(17):1343-1353. doi: 10.1161/CIRCULATIONAHA.123.068234. Epub 2024 Jul 11.

  PMID: 38989575 DERIVED

• Finnesgard EJ, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Simons JP, Schanzer A; United States Aortic Research Consortium. Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair. J Vasc Surg. 2023 Oct;78(4):892-901. doi: 10.1016/j.jvs.2023.05.034. Epub 2023 Jun 16.

  PMID: 37330702 DERIVED

• Aucoin VJ, Motyl CM, Novak Z, Eagleton MJ, Farber MA, Gasper W, Oderich GS, Mendes B, Schanzer A, Tenorio E, Timaran CH, Schneider DB, Sweet MP, Zettervall SL, Beck AW; U.S. Aortic Research Consortium. Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium. J Vasc Surg. 2023 Jun;77(6):1578-1587. doi: 10.1016/j.jvs.2023.01.205. Epub 2023 Apr 13.

  PMID: 37059239 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm, Ascending Aorta; Aneurysm, Aortic Arch

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Aneurysm, Thoracic

Study Officials

• Mark A Farber, MD

  University of North Carolina, Chapel Hill, NC 27599

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: July 31, 2012
• Study Start: July 1, 2012
• Primary Completion (Estimated): August 1, 2035
• Study Completion (Estimated): August 1, 2035
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)