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

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ClinicalTrials.gov Identifier: NCT02082834
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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).

Condition or disease Intervention/treatment Phase
Post EVAR Endoleak Detection Other: abdominal MDCT examination Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Post EVAR Endoleak Detection : Model-based Iterative Reconstruction (MBIR) vs Adaptive Statistical Iterative Reconstruction (ASIR) CTA; a Prospective Study
Study Start Date : February 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EVAR Other: abdominal MDCT examination



Primary Outcome Measures :
  1. Presence or absence of endoleak after EVAR using CT evaluation [ Time Frame: at day 1 ]

Secondary Outcome Measures :
  1. Type of endoleak, BMI (body mass index [ Time Frame: at day 1 ]
  2. Diameter of the aneurysm [ Time Frame: at day 1 ]
  3. Objective and subjective image quality [ Time Frame: at day 1 ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082834


Locations
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France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Jean Cassagnes University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02082834    
Other Study ID Numbers: CHU-0184
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014
Keywords provided by University Hospital, Clermont-Ferrand:
Endovascular aneurysm repair EVAR
Endoleak/diagnosis
VEOTM
Model-based iterative reconstruction (MBIR)
Adaptive statistical iterative reconstruction (ASIR)
Aortic Aneurysm
Low dose
Prospective
CTA
Additional relevant MeSH terms:
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Endoleak
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Postoperative Hemorrhage
Hemorrhage
Pathologic Processes
Postoperative Complications