Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01022892
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Sudhir Nagpal, Ottawa Hospital Research Institute

Brief 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.


Condition or disease
Endovascular Abdominal Aortic Aneurysm Repair

Layout table for study information
Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair
Study Start Date : September 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022892


Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Sudhir Nagpal, MD The Ottawa Hospital - Division of Vascular & Endovascular Surgery

Layout table for additonal information
Responsible Party: Dr. Sudhir Nagpal, Vascular Surgeon, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01022892     History of Changes
Other Study ID Numbers: 2007607-01H
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by Dr. Sudhir Nagpal, Ottawa Hospital Research Institute:
Endovascular
Abdominal
Aortic
Aneurysm
Repair
Surveillance
EVAR
CT
Scan
Endoleaks
Contrast
Enhanced
Ultrasound
Definity
AAA
imaging
No Endoleaks

Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases