Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm

NCT ID: NCT00488943

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Abdominal Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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AAA Endovascular Bifurcated Stent-Graft

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

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy AM Chuter, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Surgery

Joseph H Rapp, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Surgery

Linda M Reilly, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Surgery

Locations

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Division of Vascular Surgery, SFVAMC

San Francisco, California, United States

Site Status RECRUITING

Division of Vascular Surgery, UCSF

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Linda M Reilly, MD

Role: CONTACT

415 353 4366

Facility Contacts

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Shelley Dwyer, RN

Role: primary

415-750-2115

Diana Kim, MPH

Role: primary

415-353-4366

References

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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.

Reference Type BACKGROUND
PMID: 14981436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12514573 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11174813 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12663968 (View on PubMed)

Other Identifiers

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H53537-26003

Identifier Type: -

Identifier Source: org_study_id

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