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

October 18, 2023 updated by: E. Peden, MD
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital; Department of Cardiovascualr Surgery
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital; Department of Cardiovascular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoleak Detection
Time Frame: Same day outcome
Persistent of a pulsatile intrasac color flow outside the stent-graft
Same day outcome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

E. Peden, MD

Collaborators

The Methodist Hospital Research Institute
Lantheus Medical Imaging

Investigators

  • Principal Investigator: Eric Peden, MD, Houston Methodist Hosptial

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 28, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimated)

October 30, 2009

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00001211
  • 1007-0202 (Other Identifier: HMRI IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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