3D Ultrasound of Abdominal Aortic Aneurysm Characteristics for Predicting Aneurysm Shrinkage After Endovascular Repair
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysm
- Sponsor
- Rijnstate Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- lumen volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
AAA characteristics are traditionally measured with computed tomography angiography (CTA), however, three-dimensional ultrasound (3D US) is emerging as a novel imaging method for AAAs. With the use of a US contrast agent, the AAA thrombus can also be distinguished from the lumen on the 3D scans. This enables 3D visualization of the AAA and its thrombus without the need for harmful radiation and nephrotoxic contrast agents, as opposed to CTA. In in vitro measurements, 3D US has already been shown to have clinically acceptable error rate with AAA diameter and volume measurement. However, it is unclear whether this is also applicable to in vivo measurements. Therefore, the aim of this prospective study is to compare preoperative 3D US AAA characteristics as measured by 3D US with contrast enhancement (3D CEUS), 3D US without contrast enhancement (3D non-CEUS) and CTA.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Unruptured infrarenal or juxtarenal abdominal aortic aneurysm (AAA);
- •Scheduled for elective endovascular repair (EVAR);
- •Preoperative CTA with iodine contrast available;
- •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);
Outcomes
Primary Outcomes
lumen volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
Time Frame: Preoperatively
For each imaging modality, the lumen will be segmented in specialized segmentation software and then the size of the volume will be computed.
AAA volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
Time Frame: Preoperatively
For each imaging modality, the AAA will be segmented in specialized segmentation software and then the size of the volume will be computed.
maximum AAA diameter (mm) as measured by 3D non-CEUS, 3D CEUS and CTA
Time Frame: Preoperatively
For each imaging modality, the AAA and the lumen will be segmented in specialized segmentation software. Then a centerline will be computed through the lumen and perpendicular to this line, the AAA diameters are measured. From all these diameter measurements, the maximum AAA diameter will then be computed.
thrombus thickness (mm) as measured by 3D non-CEUS, 3D CEUS and CTA
Time Frame: Preoperatively
For each imaging modality, the thrombus will be segmented in specialized segmentation software and then the thrombus thickness will be computed.
thrombus volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
Time Frame: Preoperatively
For each imaging modality, the thrombus will be segmented in specialized segmentation software and then the size of the volume will be computed.
Secondary Outcomes
- Maximum AAA diameter change (mm) one-year after EVAR versus preoperative(1 year after EVAR)