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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02082834
Enrollment
90
Registered
2014-03-10
Start date
2013-02-28
Completion date
2014-02-28
Last updated
2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 .

Interventions

OTHERabdominal MDCT examination

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Presence or absence of endoleak after EVAR using CT evaluationat day 1

Secondary

MeasureTime frame
Type of endoleak, BMI (body mass indexat day 1
Diameter of the aneurysmat day 1
Objective and subjective image qualityat day 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026