Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study

Study Overview
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Brief Summary
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Cumulative radiation dose, cost, contrast induced nephrotoxicity and increased demand for computed tomography aortography (CTA) suggest that duplex ultrasonoraphy (DU) may be an alternative to CTA-based surveillance. The investigators compared CTA with DU during endovascular aneurysm repair (EVAR) follow-up. Patients undergoing EVAR have radiological follow-up data entered in a prospectively multicenter database. The gold standard test for endoleak detection was CTA. DU interpretation was performed independently of CTA and vice versa.

Official Title
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Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study

Conditions
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Endovascular Repair of Abdominal Aortic Aneurysm

Intervention / Treatment
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* Procedure: Computed tomography scan versus color duplex ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were followed after EVAR, whatever the trademark and the model of the stentgraft (bi-iliac or mono-iliac) Age > 18 years old Patient with social insurance Signature of informed consent Exclusion Criteria: patients who underwent EVAR with a fenestrated or branched stentgraft Obese patients (BMI > 30) Patients with severe renal insufficiency (Creatinine Clearance < 30 ml/mn) Patients who can't practice both an CT scan with iode injection and duplex ultrasound test over a period of one month

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Computed tomography scan versus color duplex ultrasound<br> | Procedure: Computed tomography scan versus color duplex ultrasound<br>* Computed tomography scan versus color duplex ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion) | Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion) : increasing aneurysm sac size (≥5mm), type I or type III endoleak, type II endoleak with an increasing aneurysm sac size (≥2mm) significant stenosis of a limb of the stentgraft (≥70%). | Between 1 week and 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All abnormalities, clinically significant or no | All abnormalities, clinically significant or no: All types of endoleak An increasing aneurysm sac size (≥1mm) Stenosis or thrombosis of limb of the stentgraft | Between 1 week and 1 month |