Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study
- Conditions
- Endovascular Repair of Abdominal Aortic Aneurysm
- Interventions
- Procedure: Computed tomography scan versus color duplex ultrasound
- Registration Number
- NCT01230203
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 659
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Computed tomography scan versus color duplex ultrasound Computed tomography scan versus color duplex ultrasound -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (21)
AP-HP Créteil - Service de chirurgie vasculaire
🇫🇷Créteil, France
CHU Clermont-ferrand - Service de Chirurgie Vasculaire
🇫🇷Clermont-ferrand, France
CHU de Montpellier - Service de Chirurgie Vasculaire
🇫🇷Montpellier, France
CHU d'Angers - Service de Chirurgie Vasculaire
🇫🇷Angers, France
CHU de Besançon - Service de Chirurgie Vasculaire
🇫🇷Besançon, France
CHU de Bordeaux - Service de Chirurgie Vasculaire
🇫🇷Bordeaux, France
CHU d'Amiens - Service de Chirurgie Vasculaire
🇫🇷Amiens, France
CHU de Caen - Service de Chirurgie Vasculaire
🇫🇷Caen, France
CHU de Dijon - Service de Chirurgie Vasculaire
🇫🇷Dijon, France
APHM - Hôpital Nord - Service de Chirurgie Vasculaire
🇫🇷Marseille, France
CHU de Grenoble - Service de Chirurgie Vasculaire
🇫🇷Grenoble, France
CHRU Lille Service de Chirurgie Vasculaire
🇫🇷Lille, France
HCL - Service de Chirurgie Vasculaire
🇫🇷Lyon, France
AP-HM Service de Chirurgie vasculaire
🇫🇷Marseille, France
CHU de Nice - Service de chirurgie vasculaire
🇫🇷Nice, France
CHU de Nantes - Service de Chirurgie Vasculaire
🇫🇷Nantes, France
CHU de Rouen - Service de Chirurgie Vasculaire
🇫🇷Rouen, France
AP-HP - Pitié Salpétrière - Service de Chirurgie Vasculaire
🇫🇷Paris, France
CHU de St Etienne - Service de Chirurgie Vasculaire
🇫🇷St Etienne, France
CHU de Strasbourg - Service de Chirurgie Vasculaire
🇫🇷Strasbourg, France
CHU de Toulouse - Service de Chirurgie Vasculaire
🇫🇷Toulouse, France