Concordance of Three Imaging Methods by Dynamic CT, Contrast Ultrasound and CT Angiography in the Characterization of Endoleaks in Patients With an Aortic Endoprosthesis

NCT ID: NCT06318780

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-28

Study Completion Date

2031-02-28

Brief Summary

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Among patients who have undergone EVAR, there is a significant risk of 20-50% endoleak. These endoleaks often require secondary interventions to reduce the risk of expansion or rupture. Currently, three-phase CT angiography and CEUS ultrasound are recommended in the post-operative monitoring of EVAR but these remain limited in characterizing the type and source of endoleak. In this study the investigators will study the interest of d-CTA for a better detection and characterization of endoleaks.

Detailed Description

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Conditions

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Aortic Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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three-phase CT angiography

three-phase CT angiography

Intervention Type OTHER

CEUS ultrasound

CEUS ultrasound

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years of age and older,
* Patients who have received EVAR ,
* Detection of endoleak and/or with an aneurysmal sac enlargement greater than or equal to 5 mm over 6 months.

Exclusion Criteria

* Minor patients,
* absence of endoleak and growth of the aneurysmal sac (greater than or equal to 5 mm over 6 months),
* patient under guardianship, curators, safeguard of justice,
* patient deprived of liberty,
* pregnant woman
* Patient who does not benefit from a social security scheme
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens Picardie

Amiens, Picardie, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Thierry REIX, Pr

Role: CONTACT

03.22.08.72.65

Gabriel IFERGAN, Dr

Role: CONTACT

Facility Contacts

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Thierry REIX, PhD

Role: primary

+33322455929

Other Identifiers

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PI2023_843_0171

Identifier Type: -

Identifier Source: org_study_id

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