Brief Title
Fenestrated AAA Endovascular Graft Post-Approval Study
Official Title
Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated AAA Endovascular Graft Post-Approval Study
Brief 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.
Study Type
Interventional
Primary Outcome
Treatment success : AAA related mortality
Condition
Abdominal Aortic Aneurysm
Intervention
Zenith® Fenestrated AAA Endovascular Graft
Study Arms / Comparison Groups
Zenith® Fenestrated AAA Endovascular Graft
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
21
Start Date
March 2014
Completion Date
October 12, 2020
Primary Completion Date
October 12, 2020
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01990950
Organization ID
11-005
Responsible Party
Sponsor
Study Sponsor
Cook Research Incorporated
Study Sponsor
, ,
Verification Date
November 2020