Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm
- Conditions
- Abdominal Aortic Aneurysm
- Registration Number
- NCT00488943
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- AAA with diameter > 4 cm or AAA with a history of growth > 0.5 cm per year
- treatment of AAA with Zenith Stent-Graft
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Division of Vascular Surgery, SFVAMC
đŸ‡ºđŸ‡¸San Francisco, California, United States
Division of Vascular Surgery, UCSF
đŸ‡ºđŸ‡¸San Francisco, California, United States