Post EVAR Endoleak Detection : Model-based Iterative Reco... | NCT02082834

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Feb 21, 2014

First Submission Date that Met QC Criteria

Mar 6, 2014

First Posted Date

Mar 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2014

Last Update Posted Date

Mar 10, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University Hospital, Clermont-FerrandOTHER

Collaborators

Not provided

Description Module

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 .

Conditions Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EVAR	Experimental		Other: abdominal MDCT examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
abdominal MDCT examination	Other		EVAR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence or absence of endoleak after EVAR using CT evaluation		at day 1

Secondary Outcomes

Measure	Description	Time Frame
Type of endoleak, BMI (body mass index		at day 1
Diameter of the aneurysm		at day 1
Objective and subjective image quality

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean Cassagnes	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Clermont-Ferrand		Clermont-Ferrand		63003	France

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

ID	Term
D057867	Endoleak
D004194	Disease
D001014	Aortic Aneurysm

Ancestor Terms

ID	Term
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D019106	Postoperative Hemorrhage
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications
D001018	Aortic Diseases