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Clinical Trials/NCT06318780
NCT06318780RecruitingNot Applicable

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

Centre Hospitalier Universitaire, Amiens2 sites in 1 country69 target enrollmentStarted: February 28, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
69
Locations
2
Primary Endpoint
Endoleak classification using the CT angiography

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Endoleak classification using the CT angiography

Time Frame: 5 years

Endoleak classification using the CT angiography

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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