NCT00488943

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
15.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

4.9 years

First QC Date

June 18, 2007

Last Update Submit

August 11, 2023

Conditions

Abdominal Aortic Aneurysm

Keywords

Stent-GraftAAAAbdominal Aortic AnuerysmZenithEndovascularTreatment with Zenith Aortic Stent-Graft for repair Abdominal Aortic Aneurysm

Interventions

AAA Endovascular Bifurcated Stent-GraftDEVICE

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

Also known as: Zenith AAA Endovascular Stent-Graft (Cook, Inc.)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Abdominal Aortic Aneurysms treated with Zenith Stent-Graft

You may qualify if:

  • AAA with diameter \> 4 cm or AAA with a history of growth \> 0.5 cm per year
  • treatment of AAA with Zenith Stent-Graft

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Division of Vascular Surgery, SFVAMC

San Francisco, California, 94121, United States

RECRUITING

Division of Vascular Surgery, UCSF

San Francisco, California, 94143, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 14981436BACKGROUND

  • 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.

    PMID: 12514573BACKGROUND

  • 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.

    PMID: 11174813BACKGROUND

  • 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.

    PMID: 12663968BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda M Reilly, MD

CONTACT

415 353 4366linda.reilly@ucsfmedctr.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 20, 2007

Study Start

January 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 31, 2024

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

US(2)