Other clinical trials
- Interventional trials
- Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
- Observational trials
- Address health issues in large groups of people or populations in natural settings.
- Participants are currently being recruited and enrolled.
- Active, not recruiting
- Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
- Not yet recruiting
- Participants are not yet being recruited or enrolled.
- Enrolling by invitation
- Participants are being (or will be) selected from a predetermined population.
- The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
- Study halted prematurely, prior to enrollment of first participant.
- Recruiting or enrolling participants has halted prematurely but potentially will resume.
- Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
||University of California, San Francisco
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
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
Age: 18 Years - N/A
- AAA with diameter > 4 cm or AAA with a history of growth > 0.5 cm per year
- treatment of AAA with Zenith Stent-Graft
- 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
- Joseph H Rapp, MD; Professor of Surgery (Principal Investigator)
- Linda M Reilly, MD; Professor of Surgery (Principal Investigator)
- Timothy AM Chuter, MD; Professor of Surgery (Principal Investigator)
|Division of Vascular Surgery, UCSF
||San Francisco, California
|Division of Vascular Surgery, SFVAMC
||San Francisco, California
- University of California, San Francisco - (Lead Sponsor)
- 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.
- Abdominal Aortic Anuerysm
- Treatment with Zenith Aortic Stent-Graft for repair Abdominal Aortic Aneurysm