Clinical trial NCT00488943: Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm
Official title: Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Aortic Aneurysm
Keywords: Stent-Graft
AAA
Abdominal Aortic Anuerysm
Zenith
Endovascular
Treatment with Zenith Aortic Stent-Graft for repair Abdominal Aortic Aneurysm
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2007-06-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Abdominal Aortic Aneurysms treated with Zenith Stent-Graft

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Division of Vascular Surgery, SFVAMC
state: California
city: San Francisco
country: United States
facility: Division of Vascular Surgery, UCSF
state: California
Study officials:
affiliation: Professor of Surgery
name: Timothy AM Chuter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Surgery
name: Joseph H Rapp, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Surgery
name: Linda M Reilly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.jvs.2003.12.001.
citation: 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. doi: 10.1067/mva.2003.58.
citation: 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. doi: 10.1067/mva.2001.111663.
citation: 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. doi: 10.1067/mva.2003.212.