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Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT00488358
Collaborator
(none)
10
Enrollment
1
Location
81
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    10 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft
    Study Start Date :
    Nov 1, 2005
    Actual Primary Completion Date :
    Jan 1, 2010
    Actual Study Completion Date :
    Aug 1, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Division of Vascular Surgery, UCSF San Francisco California United States 94143

      Sponsors and Collaborators

      • University of California, San Francisco

      Investigators

      • Principal Investigator: Jade S Hiramoto, MD, Assistant Professor in Residence

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University of California, San Francisco
      ClinicalTrials.gov Identifier:
      NCT00488358
      Other Study ID Numbers:
      • 10-01645
      First Posted:
      Jun 20, 2007
      Last Update Posted:
      Oct 9, 2013
      Last Verified:
      Oct 1, 2013
      Keywords provided by University of California, San Francisco
      abdominal
      aortic
      aneurysm
      Zenith
      blood pressure
      Additional relevant MeSH terms:
      Aneurysm
      Aortic Aneurysm
      Aortic Aneurysm, Abdominal

      Study Results

      No Results Posted as of Oct 9, 2013