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Recruiting 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

No phase Interventional Aortic Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: three-phase CT angiography, CEUS ultrasound.
Who it may be relevant to
Registry conditions: Aortic Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other three-phase CT angiography
    three-phase CT angiography
  • Other CEUS ultrasound
    CEUS ultrasound

Primary outcome measures

  • Endoleak classification using the CT angiography [Time frame: 5 years]
  • Variation of Endoleak classification between CEUS ultrasound and the CT angiography [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU Amiens Picardie — Amiens

Identifiers

NCT: NCT06318780 · PI2023_843_0171

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗