Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm - Full Text View

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00488943

Purpose

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	Intervention
Abdominal Aortic Aneurysm	Device: AAA Endovascular Bifurcated Stent-Graft

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Estimated Enrollment:	300
Study Start Date:	January 2005

Intervention Details:

Treatment of Abdominal Aortic Aneurysm with a Zenith Endovascular Bifurcated Stent-Graft.

Other Name: Zenith AAA Endovascular Stent-Graft (Cook, Inc.)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with Abdominal Aortic Aneurysms treated with Zenith Stent-Graft

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488943

Locations

United States, California
Division of Vascular Surgery, UCSF
San Francisco, California, United States, 94143
Division of Vascular Surgery, SFVAMC
San Francisco, California, United States, 94121

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

More Information

Publications:

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.

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.

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.

Responsible Party:	Linda M. Reilly, MD, UCSF
ClinicalTrials.gov Identifier:	NCT00488943 History of Changes
Other Study ID Numbers:	H53537-26003
Study First Received:	June 18, 2007
Last Updated:	February 26, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

Stent-Graft
AAA
Abdominal Aortic Anuerysm

Zenith
Endovascular
Treatment with Zenith Aortic Stent-Graft for repair Abdominal Aortic Aneurysm

Additional relevant MeSH terms:

Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on February 09, 2012