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RecruitingNCT06318780LEAKDYNUpdated May 25, 2025

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

An interventional study of three-phase CT angiography and CEUS ultrasound in Aortic Diseases, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Aortic Diseases

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Keywords

  • EVAR
  • d-CTA
  • CEUS
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In context

Aortic Diseases

108 studies on the registry are indexed under Aortic Diseases; 43 are open to participants now.

This study's planned enrollment of 69 is below the median of 90 across 42 interventional studies indexed under Aortic Diseases.

Browse Aortic Diseases studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants (estimated)

Interventions

  • Otherthree-phase CT angiography

    three-phase CT angiography

  • OtherCEUS ultrasound

    CEUS ultrasound

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What researchers measure

Primary outcomes

  1. Endoleak classification using the CT angiography

    Endoleak classification using the CT angiography

    Time frame: 5 years

  2. Variation of Endoleak classification between CEUS ultrasound and the CT angiography

    Variation of Endoleak classification between CEUS ultrasound and the CT angiography

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06318780
Responsible party
Sponsor
First posted
Mar 19, 2024
Start date
Feb 28, 2024
Primary completion
Feb 2029 (estimated)
Completion
Feb 2031 (estimated)
Last update
May 25, 2025

Study contacts

Thierry REIX, Pr
Contact
reix.thierry@chu-amiens.fr
03.22.08.72.65
Gabriel IFERGAN, Dr
Contact
ifergan.gabriel@chu-amiens.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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