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

Primary Purpose

Endovascular Repair of Abdominal Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Computed tomography scan versus color duplex ultrasound
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endovascular Repair of Abdominal Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Computed tomography scan versus color duplex ultrasound

Arm Description

Outcomes

Primary Outcome Measures

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%).

Secondary Outcome Measures

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

Full Information

First Posted
October 28, 2010
Last Updated
November 7, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT01230203
Brief Title
Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study
Acronym
ESSEA
Official Title
Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 16, 2010 (Actual)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
June 12, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endovascular Repair of Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
659 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computed tomography scan versus color duplex ultrasound
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Computed tomography scan versus color duplex ultrasound
Intervention Description
Computed tomography scan versus color duplex ultrasound
Primary Outcome Measure Information:
Title
Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion)
Description
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%).
Time Frame
Between 1 week and 1 month
Secondary Outcome Measure Information:
Title
All abnormalities, clinically significant or no
Description
All abnormalities, clinically significant or no: All types of endoleak An increasing aneurysm sac size (≥1mm) Stenosis or thrombosis of limb of the stentgraft
Time Frame
Between 1 week and 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassen-Khofja Reda
Organizational Affiliation
CHU de Nice - Service de Chirurgie Vasculaire
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Amiens - Service de Chirurgie Vasculaire
City
Amiens
Country
France
Facility Name
CHU d'Angers - Service de Chirurgie Vasculaire
City
Angers
Country
France
Facility Name
CHU de Besançon - Service de Chirurgie Vasculaire
City
Besançon
Country
France
Facility Name
CHU de Bordeaux - Service de Chirurgie Vasculaire
City
Bordeaux
Country
France
Facility Name
CHU de Caen - Service de Chirurgie Vasculaire
City
Caen
Country
France
Facility Name
CHU Clermont-ferrand - Service de Chirurgie Vasculaire
City
Clermont-ferrand
Country
France
Facility Name
AP-HP Créteil - Service de chirurgie vasculaire
City
Créteil
Country
France
Facility Name
CHU de Dijon - Service de Chirurgie Vasculaire
City
Dijon
Country
France
Facility Name
CHU de Grenoble - Service de Chirurgie Vasculaire
City
Grenoble
Country
France
Facility Name
CHRU Lille Service de Chirurgie Vasculaire
City
Lille
Country
France
Facility Name
HCL - Service de Chirurgie Vasculaire
City
Lyon
Country
France
Facility Name
AP-HM Service de Chirurgie vasculaire
City
Marseille
Country
France
Facility Name
APHM - Hôpital Nord - Service de Chirurgie Vasculaire
City
Marseille
Country
France
Facility Name
CHU de Montpellier - Service de Chirurgie Vasculaire
City
Montpellier
Country
France
Facility Name
CHU de Nantes - Service de Chirurgie Vasculaire
City
Nantes
Country
France
Facility Name
CHU de Nice - Service de chirurgie vasculaire
City
Nice
Country
France
Facility Name
AP-HP - Pitié Salpétrière - Service de Chirurgie Vasculaire
City
Paris
Country
France
Facility Name
CHU de Rouen - Service de Chirurgie Vasculaire
City
Rouen
Country
France
Facility Name
CHU de St Etienne - Service de Chirurgie Vasculaire
City
St Etienne
Country
France
Facility Name
CHU de Strasbourg - Service de Chirurgie Vasculaire
City
Strasbourg
Country
France
Facility Name
CHU de Toulouse - Service de Chirurgie Vasculaire
City
Toulouse
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32507018
Citation
Jean-Baptiste E, Feugier P, Cruzel C, Sarlon-Bartoli G, Reix T, Steinmetz E, Chaufour X, Chavent B, Salomon du Mont L, Ejargue M, Maurel B, Spear R, Midy D, Thaveau F, Desgranges P, Rosset E, Hassen-Khodja R; Association Universitaire de Recherche en Chirurgie Vasculaire. Computed Tomography-Aortography Versus Color-Duplex Ultrasound for Surveillance of Endovascular Abdominal Aortic Aneurysm Repair: A Prospective Multicenter Diagnostic-Accuracy Study (the ESSEA Trial). Circ Cardiovasc Imaging. 2020 Jun;13(6):e009886. doi: 10.1161/CIRCIMAGING.119.009886. Epub 2020 Jun 8.
Results Reference
derived

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

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