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

November 7, 2018 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

659

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CHU d'Amiens - Service de Chirurgie Vasculaire
      • Angers, France
        • CHU d'Angers - Service de Chirurgie Vasculaire
      • Besançon, France
        • CHU de Besançon - Service de Chirurgie Vasculaire
      • Bordeaux, France
        • CHU de Bordeaux - Service de Chirurgie Vasculaire
      • Caen, France
        • CHU de Caen - Service de Chirurgie Vasculaire
      • Clermont-ferrand, France
        • CHU Clermont-ferrand - Service de Chirurgie Vasculaire
      • Créteil, France
        • AP-HP Créteil - Service de chirurgie vasculaire
      • Dijon, France
        • CHU de Dijon - Service de Chirurgie Vasculaire
      • Grenoble, France
        • CHU de Grenoble - Service de Chirurgie Vasculaire
      • Lille, France
        • CHRU Lille Service de Chirurgie Vasculaire
      • Lyon, France
        • HCL - Service de Chirurgie Vasculaire
      • Marseille, France
        • AP-HM Service de Chirurgie vasculaire
      • Marseille, France
        • APHM - Hôpital Nord - Service de Chirurgie Vasculaire
      • Montpellier, France
        • CHU de Montpellier - Service de Chirurgie Vasculaire
      • Nantes, France
        • CHU de Nantes - Service de Chirurgie Vasculaire
      • Nice, France
        • CHU de Nice - Service de chirurgie vasculaire
      • Paris, France
        • AP-HP - Pitié Salpétrière - Service de Chirurgie Vasculaire
      • Rouen, France
        • CHU de Rouen - Service de Chirurgie Vasculaire
      • St Etienne, France
        • CHU de St Etienne - Service de Chirurgie Vasculaire
      • Strasbourg, France
        • CHU de Strasbourg - Service de Chirurgie Vasculaire
      • Toulouse, France
        • CHU de Toulouse - Service de Chirurgie Vasculaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Computed tomography scan versus color duplex ultrasound
Procedure: Computed tomography scan versus color duplex ultrasound
Computed tomography scan versus color duplex ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion)
Time Frame: 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%).
Between 1 week and 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All abnormalities, clinically significant or no
Time Frame: 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
Between 1 week and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Hassen-Khofja Reda, CHU de Nice - Service de chirurgie vasculaire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

June 12, 2015

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 7, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-APN-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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