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Trial #NCT00488943
Abdominal Aortic Aneurysm Clinical Trials

Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm


Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm
Study ID: H53537-26003; Source: University of California, San Francisco
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Definitions
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.
Recruiting
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.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Completed
Country United States
Study type Observational
Enrollment 300
Start date January 2005
Completion date
Phase N/A
Sponsor University of California, San Francisco
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.
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.
Eligibility:
Gender: Both
Age: 18 Years - N/A
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
Contacts:
  • 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)
Location Country Status
Division of Vascular Surgery, UCSF San Francisco, California United States
Division of Vascular Surgery, SFVAMC San Francisco, California United States
Sponsors:
  • University of California, San Francisco - (Lead Sponsor)

Related trials: References:
  • 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.
Terms
  • Stent-Graft
  • AAA
  • Abdominal Aortic Anuerysm
  • Zenith
  • Treatment with Zenith Aortic Stent-Graft for repair Abdominal Aortic Aneurysm
  • Endovascular
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