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
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
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
NCT ID
NCT02082834
First Posted
February 21, 2014
Last Updated
March 6, 2014
Sponsor
University Hospital, Clermont-Ferrand
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
Learn more about this trial
Post EVAR Endoleak Detection : Model-based Iterative Reconstruction (MBIR) vs Adaptive Statistical Iterative Reconstruction (ASIR) CTA; a Prospective Study
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