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

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Post EVAR Endoleak Detection

Treatments: Other: abdominal MDCT examination

Study type: Interventional

Funder types: Other

Identifiers

NCT02082834

CHU-0184

Details and patient eligibility

About

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).

Full 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 .

Enrollment: 90 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

EVAR

Experimental group

Treatment:

Other: abdominal MDCT examination