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

NCT01005212 | Completed Results

• 2 other identifiers: Pro000012111007-0202
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Endoleaks

Keywords

EVAR; Ultrasounds; AAA; endoleaks after endovascular repair of AAA

Outcome Measures

Primary Outcomes (1)

• Endoleak Detection

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

  Same day outcome

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• E. Peden, MD: lead
• Lantheus Medical Imaging: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (2)

Houston Methodist Hospital; Department of Cardiovascualr Surgery

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital; Department of Cardiovascular Surgery

Houston, Texas, 77030, United States

Location

Related Publications (29)

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MeSH Terms

Conditions

Endoleak

Interventions

perflutren

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Bevin Lopez, Clinical Trials Manager
• Organization: Houston Methodist Research Institute - Heart Center Research

balopez@houstonmethodist.org

7134413912

Study Officials

• Eric Peden, MD

  Houston Methodist Hosptial

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator/Principal Investigator

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 30, 2009
• Study Start: January 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 12, 2024
• Results First Posted: April 12, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)