Abdominal Aortic AneurysmNCT00488943
Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm
An observational study of Abdominal Aortic Aneurysm, run by University of California, San Francisco at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- AAA Endovascular Bifurcated Stent-Graft
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Abdominal Aortic Aneurysms treated with Zenith Stent-Graft
Who may be able to join
- AAA with diameter > 4 cm or AAA with a history of growth > 0.5 cm per year
- treatment of AAA with Zenith Stent-Graft
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Division of Vascular Surgery, SFVAMC
San Francisco, California, 94121
Division of Vascular Surgery, UCSF
San Francisco, California, 94143
About this study
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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- AAA Endovascular Bifurcated Stent-Graft
- Keywords
- Stent-Graft, AAA, Abdominal Aortic Anuerysm, Zenith, Endovascular, Treatment with Zenith Aortic Stent-Graft for repair Abdominal Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAA Endovascular Bifurcated Stent-GraftDevice
Also called Zenith AAA Endovascular Stent-Graft (Cook, Inc.)
Treatment of Abdominal Aortic Aneurysm with a Zenith Endovascular Bifurcated Stent-Graft.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startJan 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy AM Chuter, MD, Principal investigator, Professor of SurgeryJoseph H Rapp, MD, Principal investigator, Professor of SurgeryLinda M Reilly, MD, Principal investigator, Professor of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488943
- Sponsor's protocol ID
- H53537-26003
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2007
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.jvs.2003.12.001.
PubMed 14981436Jacobs 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.
PubMed 12514573Beebe 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.
PubMed 11174813Bertges 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.
PubMed 12663968
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT00488943
- Acronym / sponsor ID
- H53537-26003
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Stent-Graft, AAA, Abdominal Aortic Anuerysm, Zenith, Endovascular, Treatment with Zenith Aortic Stent-Graft for repair Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Abdominal Aortic Aneurysms treated with Zenith Stent-Graft
Key inclusion criteria (2 listed)
- AAA with diameter > 4 cm or AAA with a history of growth > 0.5 cm per year
- treatment of AAA with Zenith Stent-Graft
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAA Endovascular Bifurcated Stent-GraftAlso: Zenith AAA Endovascular Stent-Graft (Cook, Inc.)Treatment of Abdominal Aortic Aneurysm with a Zenith Endovascular Bifurcated Stent-Graft. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Background: PubMed 14981436Lee 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.
- Background: PubMed 12514573Jacobs 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.
- Background: PubMed 11174813Beebe 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.
- Background: PubMed 12663968Bertges 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy AM Chuter, MD principal investigator
Professor of Surgery
Joseph H Rapp, MD principal investigator
Professor of Surgery
Linda M Reilly, MD principal investigator
Professor of Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00488943, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.