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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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