Post EVAR Endoleak Detection Clinical Trial
Official title:
Post EVAR Endoleak Detection : Model-based Iterative Reconstruction (MBIR) vs Adaptive Statistical Iterative Reconstruction (ASIR) CTA; a Prospective Study
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).
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 .
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic