CompletedNot Applicable

Fenestrated AAA Endovascular Graft Post-Approval Study

United States21 participantsStarted 2014-03

Plain-language summary

This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.

Who can participate

Age range18 Years

SexALL

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: * abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm * aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair Exclusion Criteria: * proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal * renal artery stenosis greater than 50 percent

What they're measuring

Treatment Success : AAA Related Mortality

Timeframe: 5 years

Trial details

NCT IDNCT01990950

SponsorCook Research Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-12

Results submitted2021-08-17

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm (AAA) trials