Brief Title
Zenith® Low Profile AAA Endovascular Graft
Official Title
Clinical Investigation Plan for the Zenith® Low Profile AAA Endovascular Graft
Brief Summary
This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.
Study Type
Expanded Access
Condition
Abdominal Aortic Aneurysms
Intervention
Zenith Low Profile AAA Endovascular Graft
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
Eligibility Criteria
Inclusion Criteria: •Subject has at least one of the following - Aortic or aortoiliac aneurysm - Iliac aneurysm - Aneurysm with a history of growth Exclusion Criteria: - Less than 18 years of age - Inability or refusal to give informed consent - Life expectancy less than 2 years - Pregnant of breastfeeding or planning on becoming pregnant with 60 months - Unwilling to comply with the follow-up schedule
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ronald Fairman, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02557659
Organization ID
08-013 CA
Responsible Party
Sponsor
Study Sponsor
Cook Group Incorporated
Study Sponsor
Ronald Fairman, MD, Principal Investigator, University of Pennsylvania
Verification Date
March 2018