Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft

NCT ID: NCT00488358

Last Updated: 2013-10-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2012-08-31

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jade S Hiramoto, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor in Residence

Locations

Division of Vascular Surgery, UCSF

San Francisco, California, United States

Countries

United States

Other Identifiers

10-01645

Identifier Type: -

Identifier Source: org_study_id