Brief Title
Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
Official Title
Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
Brief Summary
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.
Study Type
Interventional
Primary Outcome
Patients With Major Adverse Events (MAE)
Condition
Abdominal Aortic Aneurysms
Intervention
Zenith(R) Low Profile AAA Endovascular Graft
Study Arms / Comparison Groups
1
Description: Treatment with 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
Estimated Enrollment
120
Start Date
May 2008
Completion Date
June 2016
Primary Completion Date
October 2011
Eligibility Criteria
Inclusion Criteria: - Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size - Vessels suitable for endovascular access and aneurysm repair Exclusion Criteria: - Less than 18 years of age - Inability or refusal to give informed consent - Disease considerations that would compromise patient safety or study outcomes - Unsuitable arterial anatomy
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ronald Fairman, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT00833924
Organization ID
08-013
Secondary IDs
370016
Responsible Party
Sponsor
Study Sponsor
Cook Group Incorporated
Study Sponsor
Ronald Fairman, MD, Principal Investigator, University of Pennsylvania
Verification Date
March 2018