Endovascular Repair of Abdominal Aortic Aneurysm
Conditions
Brief summary
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.
Interventions
PROCEDUREComputed tomography scan versus color duplex ultrasound
Computed tomography scan versus color duplex ultrasound
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion) | Between 1 week and 1 month | 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%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All abnormalities, clinically significant or no | Between 1 week and 1 month | All abnormalities, clinically significant or no: All types of endoleak An increasing aneurysm sac size (≥1mm) Stenosis or thrombosis of limb of the stentgraft |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORHassen-Khofja Reda
CHU de Nice - Service de Chirurgie Vasculaire
Outcome results
None listed