Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair

Ottawa Hospital Research Institute

Status: Completed

Conditions: Endovascular Abdominal Aortic Aneurysm Repair

Study type: Observational

Funder types: Other

Identifiers

NCT01022892

2007607-01H

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

140 participants in 2 patient groups

Phase 1 - Pilot phase

Description:

Total of 10 patients currently undergoing EVAR Surveillance. These 10 patients include 5 patients with endoleak known from a recent CT scan and 5 patients with no endoleak and shrinking aneurysm.

Phase 2 - Blinded from CT Scan

Description:

This phase of study involves recruitment of 150 patients currently under post-EVAR surveillance. The physicians and ultrasound technologists will be blinded to the result of the CT Scan when performing and interpreting the CUS. The current schedule for EVAR Surveillance will be maintained so that an individual may receive more than one enhanced CT Scan and CUS during the 18 months of the study.