Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair (AAA CEUS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Endoleaks |
Drug: Definity |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair |
- To examine the sensitivity and specificity of CEUS compared to CTA Hypothesis [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | January 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
-
Drug: Definity
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Sujbects that have undgone endovascular repair of abdominal aortic aneurysms (EVAR).
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.
Contacts and Locations| United States, Texas | |
| The Methodist Hospital; Department of Cardiovascualr Surgery | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Eric Peden, MD | The Methodist Hosptial |
More Information
Publications:
| Responsible Party: | The Methodist Hospital System |
| ClinicalTrials.gov Identifier: | NCT01005212 History of Changes |
| Other Study ID Numbers: | 1007-0202 |
| Study First Received: | October 28, 2009 |
| Last Updated: | May 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The Methodist Hospital System:
|
EVAR Ultrasounds AAA endoleaks after endovascular repair of AAA |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Endoleak Vascular Diseases Cardiovascular Diseases |
Aortic Diseases Postoperative Hemorrhage Hemorrhage Pathologic Processes Postoperative Complications |
ClinicalTrials.gov processed this record on May 19, 2013