Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair

March 5, 2012 updated by: Dr. Sudhir Nagpal, Ottawa Hospital Research Institute

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients who underwent EVAR at The Ottawa Hospital and are currently undergoing post-EVAR surveillance will be eligible for the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Phase 1 - Pilot phase
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Sudhir Nagpal, MD, The Ottawa Hospital - Division of Vascular & Endovascular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

November 26, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 5, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007607-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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