By InvitationNot Applicable

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

United States770 participantsStarted 2012-07

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aortic Aneurysm 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

Exclusion criteria

✕. Less than 18 years of age
✕. Unwilling to comply with the follow-up schedule
✕. Inability or refusal to give informed consent
✕. Inadequate femoral/iliac access compatible with the required delivery systems;
✕. Does not have a non-aneurysmal aortic segment proximal to the aneurysm with:
✕. Does not have visceral vessel anatomy compatible with Zenith® p-Branch™, specifically:
✕. A proximal seal site with unsuitable thrombus/atheroma
✕. Does not have iliac artery fixation sites and anatomy consistent with:

What they're measuring

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

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

Trial details

NCT IDNCT01654133

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2035-08

View on ClinicalTrials.gov More Aortic Aneurysm, Abdominal trials