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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06318780
Acronym
LEAKDYN
Enrollment
69
Registered
2024-03-19
Start date
2024-02-28
Completion date
2031-02-28
Last updated
2025-05-25

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

Conditions

Aortic Diseases

Keywords

EVAR, d-CTA, CEUS

Brief summary

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.

Interventions

OTHERthree-phase CT angiography

three-phase CT angiography

OTHERCEUS ultrasound

CEUS ultrasound

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Endoleak classification using the CT angiography5 yearsEndoleak classification using the CT angiography
Variation of Endoleak classification between CEUS ultrasound and the CT angiography5 yearsVariation of Endoleak classification between CEUS ultrasound and the CT angiography

Countries

France

Contacts

Primary ContactThierry REIX, Pr
reix.thierry@chu-amiens.fr03.22.08.72.65
Backup ContactGabriel IFERGAN, Dr
ifergan.gabriel@chu-amiens.fr

Outcome results

None listed

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