Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair

Conditions
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Endoleaks

Intervention / Treatment
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* Drug: Definity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years of age or greater; Diagnosed with abdominal aortic aneurysm and has undergone or is scheduled to undergo endovascular repair procedure. Has not completed the first scheduled post-treatment follow-up exam Voluntary participation and signature of IRB-approved informed consent. Exclusion Criteria: Inability to consent (includes non-English speaking patients) Has already completed the first scheduled post-treatment follow-up exam. Clinical instability; Pregnancy / breast feeding; Known allergy to perflutren; Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts (based on manufacturer recommendations for use); Recent heart attack (<6 months), unstable angina or uncontrolled cardiopulmonary disease Clinically unstable or recent worsening congestive heart failure (based on FDA warning) Serious ventricular arrhythmias or at high risk for arrhythmias Respiratory failure (based on FDA warning) Severe emphysema, pulmonary emboli or other conditions that compromise pulmonary arterial vasculature (based on FDA warning) Any reason judged by the investigators to hamper inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Definity|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the sensitivity and specificity of CEUS compared to CTA Hypothesis |  | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasounds, EVAR, AAA, endoleaks after endovascular repair of AAA