Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair

Endovascular Abdominal Aortic Aneurysm Repair Clinical Trial

Official title:

Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022892
• Other study ID #: 2007607-01H
• Status: Completed
• Phase: N/A
• First received: November 26, 2009
• Last updated: March 5, 2012
• Start date: September 2009
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to support the suspected expectation that Contrast enhanced Ultrasound (CUS) detects all endoleaks that have been detected by Computed Tomography (CT), and also find a number of leaks missed by CT.

The investigators' primary goal is to detect no difference between CT and CUS and provide evidence that CUS is a possible alternative to CT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients who underwent EVAR at The Ottawa Hospital and currently under post-EVAR surveillance at The Ottawa Hospital.

Exclusion Criteria:

• Unable to consent for injection of contrast

• Unable to acquire IV access

• Right-to-left, bi-directional, or transient right-to-left cardiac shunts

• Severe pulmonary disease

• Previous hypersensitivity to DEFINITY® or its components

• Unable to be followed as a outpatient by the Vascular Diagnostic Center

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Endovascular Abdominal Aortic Aneurysm Repair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute