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

Enrolling by invitation · Not applicable

Conditions studied: Aortic Aneurysm, Abdominal, Ascending Aorta Aneurysm, Aortic Arch Aneurysm

In brief

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

Key facts

Study ID

NCT01654133

Run by

University of North Carolina, Chapel Hill

People needed

770

Starts

2012-07-01

Expected to finish

2035-08-01

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• General Exclusion Criteria
• 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
• Medical Exclusion Criteria
• 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
• Anatomical Exclusion Criteria
• 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)
• Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) >21 mm at distal fixation site
• Iliac artery distal fixation site <10 mm in length
• Inability to preserve at least one hypogastric artery
• Cohort 2 (ascending/aortic arch) Inclusion Criteria:
• General Inclusion Criteria:
• Treatment not possible with a currently available non-modified approved device
• Patient accepts to and is able to comply with lifetime follow-up

Where it is running

• UNC Heart and Vascular — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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