Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair (AAA CEUS)

This study has been completed.
Sponsor:
Collaborator:
Lantheus Medical Imaging
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01005212
First received: October 28, 2009
Last updated: May 21, 2012
Last verified: May 2012
  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

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Drug: Definity
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Sujbects that have undgone endovascular repair of abdominal aortic aneurysms (EVAR).

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01005212

Locations
United States, Texas
The Methodist Hospital; Department of Cardiovascualr Surgery
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Lantheus Medical Imaging
Investigators
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 July 28, 2014