Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair
Status: | Completed |
---|---|
Conditions: | Cardiology, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/4/2017 |
Start Date: | January 2008 |
End Date: | September 2010 |
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.
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.
Inclusion Criteria:
1. Age 18 years of age or greater;
2. Diagnosed with abdominal aortic aneurysm and has undergone or is scheduled to undergo
endovascular repair procedure.
3. Has not completed the first scheduled post-treatment follow-up exam
4. Voluntary participation and signature of IRB-approved informed consent.
Exclusion Criteria:
1. Inability to consent (includes non-English speaking patients)
2. Has already completed the first scheduled post-treatment follow-up exam.
3. Clinical instability;
4. Pregnancy / breast feeding;
5. Known allergy to perflutren;
6. Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac
shunts (based on manufacturer recommendations for use);
7. Recent heart attack (<6 months), unstable angina or uncontrolled cardiopulmonary
disease
8. Clinically unstable or recent worsening congestive heart failure (based on FDA
warning)
9. Serious ventricular arrhythmias or at high risk for arrhythmias
10. Respiratory failure (based on FDA warning)
11. Severe emphysema, pulmonary emboli or other conditions that compromise pulmonary
arterial vasculature (based on FDA warning)
12. Any reason judged by the investigators to hamper inclusion.
We found this trial at
2
sites
6550 Fannin Street
Houston, Texas 77030
Houston, Texas 77030
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6565 Fannin Street
Houston, Texas 77030
Houston, Texas 77030
Click here to add this to my saved trials