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

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.

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Key information

Conditions

Endoleaks Aneurysm Cardiovascular Diseases Endoleak Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Definity

Drug

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.

Primary outcomes

Endoleak Detection

Time frame: Same day outcome

Persistent of a pulsatile intrasac color flow outside the stent-graft

Sponsors and collaborators

Lead sponsor

E. Peden, MD

Other

Collaborators

Lantheus Medical Imaging
The Methodist Hospital Research Institute

Registry information

Acronym: AAA CEUS

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Oct 30, 2009
Registry last updated: Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed