Endoleaks
Conditions
Keywords
EVAR, Ultrasounds, AAA, endoleaks after endovascular repair of AAA
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.
Interventions
DRUGDefinity
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.
Sponsors
Lantheus Medical Imaging
The Methodist Hospital Research Institute
E. Peden, MD
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoleak Detection | Same day outcome | Persistent of a pulsatile intrasac color flow outside the stent-graft |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm AAA patients | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 70 years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Endoleak Detection
Persistent of a pulsatile intrasac color flow outside the stent-graft
Time frame: Same day outcome
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Endoleak Detection | 9 Participants |