Brief Title
Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm
Official Title
Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm
Brief Summary
To collect and analyze clinical follow-up data which can be used to assess the safety, efficacy, and durability of endovascular AAA repair with Zenith and Chuter-Gianturco stent-grafts.
Detailed Description
We propose to analyze the data collected for clinical purposes in 453 patients who already underwent endovascular AAA repair at UCSF and SFVA, and others who will undergo this operation in the future. Most of these patients have now passed the 2-year follow-up required by the original protocol, all continue to be followed for clinical purposes, using the same studies, the same data forms and the same schedule as before, because studies of various devices of this type have shown that the potential for late problems requires continuing scrutiny of stent-graft structure and function, as a basis for timely re-intervention.
Study Type
Observational
Condition
Abdominal Aortic Aneurysm
Intervention
AAA Endovascular Bifurcated Stent-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
300
Start Date
January 2005
Primary Completion Date
December 2009
Eligibility Criteria
Inclusion Criteria: - AAA with diameter > 4 cm or AAA with a history of growth > 0.5 cm per year - treatment of AAA with Zenith Stent-Graft Exclusion Criteria: - Pregnant - Life expectancy less than two years - Less than 18 years of age - Unwilling to comply with clinical follow-up schedule - Inability or refusal to give informed consent
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Timothy AM Chuter, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00488943
Organization ID
H53537-26003
Responsible Party
Sponsor
Study Sponsor
University of California, San Francisco
Study Sponsor
Timothy AM Chuter, MD, Principal Investigator, Professor of Surgery
Verification Date
June 2012