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Post EVAR Endoleak Detection : Model-based Iterative Reconstruction (MBIR) vs Adaptive Statistical Iterative Reconstruction (ASIR) CTA; a Prospective Study

Primary Purpose

Post EVAR Endoleak Detection

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
abdominal MDCT examination
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post EVAR Endoleak Detection focused on measuring Endovascular aneurysm repair EVAR, Endoleak/diagnosis, VEOTM, Model-based iterative reconstruction (MBIR), Adaptive statistical iterative reconstruction (ASIR), Aortic Aneurysm, Low dose, Prospective, CTA

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • informed and a written consent
  • all patients consulting to follow up his EVAR
  • 18-90 years
  • French

Exclusion Criteria:

  • pregnant
  • juvenile patients
  • patient who refusal the study
  • CI of contrast iodine injection : CI of ultravist
  • llergy
  • renal failure creatinemy <30 ml/min

Sites / Locations

  • CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EVAR

Arm Description

Outcomes

Primary Outcome Measures

Presence or absence of endoleak after EVAR using CT evaluation

Secondary Outcome Measures

Type of endoleak, BMI (body mass index
Diameter of the aneurysm
Objective and subjective image quality

Full Information

First Posted
February 21, 2014
Last Updated
March 6, 2014
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02082834
Brief Title
Post EVAR Endoleak Detection : Model-based Iterative Reconstruction (MBIR) vs Adaptive Statistical Iterative Reconstruction (ASIR) CTA; a Prospective Study
Official Title
Post EVAR Endoleak Detection : Model-based Iterative Reconstruction (MBIR) vs Adaptive Statistical Iterative Reconstruction (ASIR) CTA; a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to compare the accuracy of the diagnosis of endoleak in patient with EVAR comparing Adaptive statistical iterative reconstruction (ASIR) CTA and Model-based iterative reconstruction (MBIR- VEO TM).
Detailed Description
Background: The aortic aneurysm is a common and serious disease share its complications (rupture ) , often fatal. It is recognized that pass a certain diameter surgical or endovascular treatment reduces mortality by avoiding treatment in extreme provider of high morbidity and mortality emergency. Endovascular anevrysm repair (EVAR) treatment has proven effective but unfortunately this treatment presents complications ( endoleak ) should be sought systematically by repeated checks CT . The irradiation in these patients is a major problem with repeated exposure radiation. The follow up of these patients requires repeated CT because endoleaks can be delayed. Iterative reconstruction of previous generation have reduced the dose , we dispose the last Model-based iterative reconstruction (" VEO " ) for a further reduction of patient dose . This technique has not yet been evaluated in the detection of endoleaks. The purpose of the study is to compare conventional CTA (ASIR50) ( gold standard now) with Model-based iterative reconstruction (MBIR- VEO TM) in the detection ( and classification ) of endoleaks in patients traited by EVAR. All patient admited in Radiology to follow up his EVAR is included in the study and receive both CT: Adaptive statistical iterative reconstruction (ASIR) CTA and Model-based iterative reconstruction (MBIR- VEO TM) and the result of thoses 2 CT are compared by 2 readers (blinded of the result) The BMI , other complications, the DLP , dose reduction and quality of the examination is noted .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post EVAR Endoleak Detection
Keywords
Endovascular aneurysm repair EVAR, Endoleak/diagnosis, VEOTM, Model-based iterative reconstruction (MBIR), Adaptive statistical iterative reconstruction (ASIR), Aortic Aneurysm, Low dose, Prospective, CTA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVAR
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
abdominal MDCT examination
Primary Outcome Measure Information:
Title
Presence or absence of endoleak after EVAR using CT evaluation
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Type of endoleak, BMI (body mass index
Time Frame
at day 1
Title
Diameter of the aneurysm
Time Frame
at day 1
Title
Objective and subjective image quality
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: informed and a written consent all patients consulting to follow up his EVAR 18-90 years French Exclusion Criteria: pregnant juvenile patients patient who refusal the study CI of contrast iodine injection : CI of ultravist llergy renal failure creatinemy <30 ml/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Cassagnes
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

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Post EVAR Endoleak Detection : Model-based Iterative Reconstruction (MBIR) vs Adaptive Statistical Iterative Reconstruction (ASIR) CTA; a Prospective Study

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