Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00488943
• Other study ID #: H53537-26003
• Status: Recruiting
• Start date: January 2005
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Linda M Reilly, MD
• Phone: 415 353 4366
• Email: linda.reilly[@]ucsfmedctr.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• AAA Endovascular Bifurcated Stent-Graft
Treatment of Abdominal Aortic Aneurysm with a Zenith Endovascular Bifurcated Stent-Graft.

Locations

Country	Name	City	State
United States	Division of Vascular Surgery, SFVAMC	San Francisco	California
United States	Division of Vascular Surgery, UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation