Using US to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous CT Scan

Study Overview
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Brief Summary
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Examine a new method based on fusion between ultrasound (US) and previous ultrasound/computerized tomography(US/CT) studies to evaluate the size of abdominal aneurysm and measure the changes over time and following invasive repair procedure.

Detailed Description
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Selection test for assessing aortic aneurysm is CT angio, it performed after injection of contrast material and allows a complete demonstration of the blood vessels. This test exposes the patient to ionizing radiation and the injection of iodine contrast medium. Repeated tests pose a risk of developing a malignancy in the future due to the use of ionizing radiation and risk of renal impairment and allergic reactions due to the injection of contrast material. Ultrasound is another test that enables the detection and evaluation of aortic aneurysm. Patients with a known diagnosis of aortic aneurysm detected on CT are required to continuous monitoring in light of its growth over time and the risk of rupture. Using Co-registration over the US device will enable to conduct a US directed aorta examination, which uses the information produced from the CT as a roadmap for detection and localization of the aneurysm. That can theoretically improve detection capabilities and characteristics of the aneurysm and outcomes of the invasive treatment.

Official Title
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Using Ultrasound to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous Computerized Tomography

Conditions
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Aortic Aneurysm, Abdominal

Intervention / Treatment
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* Device: US-CT Fusion examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: •Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it. Exclusion Criteria: Inability to perform Ultrasound Pace maker Hemodynamic instability Inability to cooperate in US examination Pregnant Women - does not undergo CT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with known aortic aneurysm<br>Patients with known abdominal aortic aneurysm diagnosed in clinical follow-up or after an invasive procedure to repair it. US-CT Fusion examination | Device: US-CT Fusion examination<br>* Patients will undergo an US examination using an US device with US-CT Fusion capabilities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exact and reliable evaluation of the aneurysm size | The size of the aneurysm will be evaluated by two different doctors or twice with large time frame between the studies. The difference between the measurements with the fusion technology will be compared to the difference without the fusion technology. The accuracy of the measurement will be evaluated by comparing to previous CT examination. | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The size difference between systolic and diastolic aneurysm. |  | two years | 
| Aneurysm neck size and changes following an invasive procedure to repair it (EVAR). |  | two years | 
| Evaluation of the pressure on the aneurysmal wall. |  | two years |