An interventional study of abdominal MDCT examination in Post EVAR Endoleak Detection, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-03-10.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic
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 .
29 studies on the registry are indexed under Endoleak; 6 are open to participants now.
This study's enrollment of 90 is above the median of 44 across 17 interventional studies indexed under Endoleak.
Browse Endoleak studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
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Exclusion Criteria:
Other: abdominal MDCT examination
Presence or absence of endoleak after EVAR using CT evaluation
Time frame: at day 1
Type of endoleak, BMI (body mass index
Time frame: at day 1
Diameter of the aneurysm
Time frame: at day 1
Objective and subjective image quality
Time frame: at day 1
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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