Clinical trial NCT01005212: Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair
Official title: Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoleaks
Keywords: EVAR
Ultrasounds
AAA
endoleaks after endovascular repair of AAA
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Lantheus Medical Imaging
name: The Methodist Hospital Research Institute
First posted: 2009-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that have undgone endovascular repair of abdominal aortic aneurysms (EVAR).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Endoleak Detection
timeFrame: Same day outcome
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital; Department of Cardiovascualr Surgery
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital; Department of Cardiovascular Surgery
state: Texas
Study officials:
affiliation: Houston Methodist Hosptial
name: Eric Peden, MD
role: PRINCIPAL_INVESTIGATOR
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