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

Not Applicable

Completed

• Conditions: Endovascular Repair of Abdominal Aortic Aneurysm

• 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

Study Timeline

• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-10-29
• Study Start: 2010-12-16
• Primary Completion: 2012-11
• Study Completion: 2015-06-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-07
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 659

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)

CHU d'Amiens - Service de Chirurgie Vasculaire; 🇫🇷 Amiens, 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 de Caen - Service de Chirurgie Vasculaire; 🇫🇷 Caen, France

CHU Clermont-ferrand - Service de Chirurgie Vasculaire; 🇫🇷 Clermont-ferrand, France

AP-HP Créteil - Service de chirurgie vasculaire; 🇫🇷 Créteil, France

CHU de Dijon - Service de Chirurgie Vasculaire; 🇫🇷 Dijon, France

CHU de Grenoble - Service de Chirurgie Vasculaire; 🇫🇷 Grenoble, France

CHRU Lille Service de Chirurgie Vasculaire; 🇫🇷 Lille, France

Scroll for more (11 remaining)