Abdominal Aortic AneurysmNCT00488358
Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft
An observational study of Abdominal Aortic Aneurysm, run by University of California, San Francisco at 1 site in United States.
Trial summary
To compare the aortic pulse profile before and after stent-graft implantation to prove that endovascular AAA repair using non-compliant stent-graft changes the aortic pulse profile. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Aug 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft
Who may be able to join
- Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Vascular Surgery, UCSF
San Francisco, California, 94143
About this study
To compare the aortic pulse profile before and after stent-graft implantation to prove that endovascular AAA repair using non-compliant stent-graft changes the aortic pulse profile.
Read the detailed description
This study will assess hemodynamic changes in aortas of patients after treatment of their abdominal aortic aneurysm (AAA) with an FDA approved stent-graft (Zenith). This study does not require any change in clinical protocol to the the way the AAA procedures are currently done. Utilizing the catheters already employed in this procedure, intravascular blood pressure measurements will be documented at various times and at various anatomic levels prior to and after deployment of the stent-graft.
As the compliant aortic aneurysm acts as a capacitor, expanding during systole and contracting during diastole, it is our hypothesis that endovascular AAA repair using a non-compliant stent-graft changes the aortic pulse profile.
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- abdominal, aortic, aneurysm, Zenith, blood pressure
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
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 startNov 2005
- Primary completionJan 2010
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jade S Hiramoto, MD, Principal investigator, Assistant Professor in Residence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488358
- Sponsor's protocol ID
- 10-01645
- Status last verified
- Oct 2013
- First submitted
- 18 Jun 2007
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft
- ClinicalTrials.gov ID
- NCT00488358
- Acronym / sponsor ID
- 10-01645
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- abdominal, aortic, aneurysm, Zenith, blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Aug 2012 (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 compare the aortic pulse profile before and after stent-graft implantation to prove that endovascular AAA repair using non-compliant stent-graft changes the aortic pulse profile.
Detailed description
This study will assess hemodynamic changes in aortas of patients after treatment of their abdominal aortic aneurysm (AAA) with an FDA approved stent-graft (Zenith). This study does not require any change in clinical protocol to the the way the AAA procedures are currently done. Utilizing the catheters already employed in this procedure, intravascular blood pressure measurements will be documented at various times and at various anatomic levels prior to and after deployment of the stent-graft.
As the compliant aortic aneurysm acts as a capacitor, expanding during systole and contracting during diastole, it is our hypothesis that endovascular AAA repair using a non-compliant stent-graft changes the aortic pulse profile.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft
Key inclusion criteria (1 listed)
- Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 9 Oct 2013.
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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.
Jade S Hiramoto, MD principal investigator
Assistant Professor in Residence
1 site 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 1 site 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 1 inclusion and 0 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 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 9 Oct 2013; AzTrials last refreshed its copy on 6 Nov 2026.