CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Definitydrug
Likely dose
Definity 1.3 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01005212
NCT01005212N/ACompleted
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Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair

E. Peden, MD·observational·Posted Oct 30, 2009·Updated Apr 12, 2024

In Brief

An observational study evaluating Definity for Endoleaks. Completed, enrolled 20 participants across 2 sites.

Detailed Summary

This study will be a cross-sectional survey of interobserver variability associated with contrast enhanced ultrasound (CEUS) to detect endoleaks using computed tomographic angiography (CTA) as the practice standard. The investigators will enroll 40 consecutive patients undergoing endovascular abdominal aortic aneurysm repair (EVAR). At the first follow-up visit after the procedure, participants will undergo two abdominal ultrasound examinations with and without contrast, and one CTA. Analyses will be conducted to examine interobserver variability in the detection and characterization of endoleaks using contrast-enhanced ultrasound (CEUS). Other endpoints include examination of sensitivity and specificity of CEUS compared to CTA, and characterization of the number and types of endoleaks detected.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsEndoleaks
CountriesUnited States
CollaboratorsLantheus Medical Imaging, The Methodist Hospital Research Institute

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 30, 2009
Enrollment StartJan 1, 2008
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.7 years ago

Interventions

Definitydrug

An intravenous line will be placed and 1.3 mL of the ultrasound contrast agent DEFINITY® will be added to 50 mL sterile saline. Flow will be initiated at 4.0 mL/minute and adjusted for optimal imaging. A maximum of 1.3 mL or one vial of ultrasound contrast will be used per patient per session according to the manufacturer's guidelines.