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NCT00488358 Clinical Trial

Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft

Abdominal Aortic Aneurysm Clinical Trial

Official title:
Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00488358
Other study ID # 10-01645
Secondary ID
Status Completed
Phase N/A
First received June 18, 2007
Last updated October 8, 2013
Start date November 2005
Est. completion date August 2012

Study information
Verified date October 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 2012
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Division of Vascular Surgery, UCSF San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

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