Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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AAA with diameter > 4 cm or AAA with a history of growth > 0.5 cm per year
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treatment of AAA with Zenith Stent-Graft
Exclusion Criteria:
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Pregnant
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Life expectancy less than two years
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Less than 18 years of age
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Unwilling to comply with clinical follow-up schedule
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Inability or refusal to give informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Division of Vascular Surgery, SFVAMC | San Francisco | California | United States | 94121 |
| 2 | Division of Vascular Surgery, UCSF | San Francisco | California | United States | 94143 |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Timothy AM Chuter, MD, Professor of Surgery
- Principal Investigator: Joseph H Rapp, MD, Professor of Surgery
- Principal Investigator: Linda M Reilly, MD, Professor of Surgery
Study Documents (Full-Text)
None provided.More Information
Publications
- Beebe HG, Cronenwett JL, Katzen BT, Brewster DC, Green RM; Vanguard Endograft Trial Investigators. Results of an aortic endograft trial: impact of device failure beyond 12 months. J Vasc Surg. 2001 Feb;33(2 Suppl):S55-63.
- Bertges DJ, Chow K, Wyers MC, Landsittel D, Frydrych AV, Stavropoulos W, Tan WA, Rhee RY, Fillinger MF, Fairman RM, Makaroun MS. Abdominal aortic aneurysm size regression after endovascular repair is endograft dependent. J Vasc Surg. 2003 Apr;37(4):716-23.
- Jacobs TS, Won J, Gravereaux EC, Faries PL, Morrissey N, Teodorescu VJ, Hollier LH, Marin ML. Mechanical failure of prosthetic human implants: a 10-year experience with aortic stent graft devices. J Vasc Surg. 2003 Jan;37(1):16-26.
- Lee WA, Carter JW, Upchurch G, Seeger JM, Huber TS. Perioperative outcomes after open and endovascular repair of intact abdominal aortic aneurysms in the United States during 2001. J Vasc Surg. 2004 Mar;39(3):491-6.
- H53537-26003