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

Completed

• Conditions: Endoleaks

• Registration Number: NCT01005212
• Lead Sponsor: E. Peden, MD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-10-28
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2023-10
• Results First Submitted: 2023-10-18
• Results First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Results First Posted: 2024-04-12
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endoleak Detection	Same day outcome	Persistent of a pulsatile intrasac color flow outside the stent-graft

Trial Locations

Locations (2)

Houston Methodist Hospital; Department of Cardiovascular Surgery; 🇺🇸 Houston, Texas, United States

Houston Methodist Hospital; Department of Cardiovascualr Surgery; 🇺🇸 Houston, Texas, United States