3D ultrasound of abdominal aortic aneurysm characteristics for predicting aneurysm shrinkage after endovascular repair

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

• Age >= 18 years;
• Unruptured infrarenal or juxtarenal abdominal aortic aneurysm (AAA);
• Scheduled for elective endovascular repair (EVAR);
• Preoperative CTA with iodine contrast scheduled or already made;
• Informed consent form understood and signed.

Exclusion Criteria

• BMI>40 kg/m2;
• Symptomatic AAA;
• Implanted pacemaker or ICD;
• Unable to hold breath for <=7 seconds;
• Pregnant;
• Hypersensitivity to the active substance(s) or any of the excipients in
Sonovue;
• Known right-to-left cardiac shunt;
• Severe pulmonary hypertension (pulmonary artery pressure > 90mmHg);
• Uncontrolled systemic hypertension;
• Severe pulmonary disease (e.g. COPD GOLD 3 or 4, adult respiratory distress
syndrome);
• Clinically unstable cardiac disease (recent, < 3 months, or ongoing
myocardial infarction, unstable angina at rest, recent percutaneous coronary
intervention, clinically worsening cardiac symptoms, severe cardiac
arrhythmia*s, endocarditis, etc.);
• Prosthetic valves;
• Loss of renal function (GFR < 31 mL/min), end-stage renal disease;
• End-stage liver disease;
• Sepsis;
• Hypercoagulable status, recent (< 3 months) thrombosis;
• Congestive heart failure (class III or IV);
• Psychiatric or other condition that may interfere with the study;
• Participating in another clinical study that interferes on the primary
outcomes of this study;
• 3D US measurement of AAA is impossible because of bowel gasses or other
causes.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the comparison between 3D non-CEUS, 3D CEUS and CTA<br /><br>in measuring preoperative AAA characteristics, including AAA diameter, AAA<br /><br>volume, lumen volume, thrombus thickness and thrombus volume.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints are:<br /><br>- Feasibility of 3D CEUS of AAAs;<br /><br>- Added value of contrast enhancement during 3D US;<br /><br>- Category of AAA sac remodeling one-year after EVAR;<br /><br>- Predictors of AAA sac remodeling one-year after EVAR.</p><br>