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Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00488358
First received: June 18, 2007
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

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
Abdominal Aortic Aneurysm

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 10
Study Start Date: November 2005
Estimated Study Completion Date: August 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft

Criteria

Inclusion Criteria:

  • Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488358

Locations
United States, California
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
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00488358     History of Changes
Other Study ID Numbers: 10-01645
Study First Received: June 18, 2007
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
abdominal
aortic
aneurysm
Zenith
blood pressure

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 19, 2013