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NCT Number: NCT06318780

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

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.

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Key information

Conditions

Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Thierry REIX, PhD

CONTACT

[email protected]

+33322455929

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

three-phase CT angiography

Other

three-phase CT angiography

CEUS ultrasound

Other

CEUS ultrasound

Primary outcomes

  1. Endoleak classification using the CT angiography

    Time frame: 5 years

    Endoleak classification using the CT angiography

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

    Time frame: 5 years

    Variation of Endoleak classification between CEUS ultrasound and the CT angiography

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel IFERGAN, Dr

CONTACT

[email protected]

Thierry REIX, Pr

CONTACT

[email protected]

03.22.08.72.65

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: LEAKDYN

Important dates

Study start
2024
Primary completion
2029
Study completion
2031
First posted
Mar 19, 2024
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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