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

Aortic Diseases Clinical Trial

— LEAKDYN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318780
• Other study ID #: PI2023_843_0171
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: February 2031

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Thierry REIX, Pr
• Phone: 03.22.08.72.65
• Email: reix.thierry[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: February 2031
• Est. primary completion date: February 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Diseases
• Endoleak

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoleak classification using the CT angiography	Endoleak classification using the CT angiography	5 years
Primary	Variation of Endoleak classification between CEUS ultrasound and the CT angiography	Variation of Endoleak classification between CEUS ultrasound and the CT angiography	5 years