Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair
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|ClinicalTrials.gov Identifier: NCT01022892|
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : March 7, 2012
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|
|Study Type :||Observational|
|Actual Enrollment :||140 participants|
|Observational Model:||Case Control|
|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|
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.
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
|Principal Investigator:||Sudhir Nagpal, MD||The Ottawa Hospital - Division of Vascular & Endovascular Surgery|