NCT06318780

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
56mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Feb 2024Feb 2031

Study Start

First participant enrolled

February 28, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2031

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

4.9 years

First QC Date

March 12, 2024

Last Update Submit

May 21, 2025

Conditions

Aortic Diseases

Keywords

EVARd-CTACEUS

Outcome Measures

Primary Outcomes (2)

  • Endoleak classification using the CT angiography

    Endoleak classification using the CT angiography

    5 years

  • Variation of Endoleak classification between CEUS ultrasound and the CT angiography

    Variation of Endoleak classification between CEUS ultrasound and the CT angiography

    5 years

Interventions

three-phase CT angiographyOTHER

three-phase CT angiography

CEUS ultrasoundOTHER

CEUS ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Aortic Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Thierry REIX, Pr

CONTACT

03.22.08.72.65reix.thierry@chu-amiens.fr

Gabriel IFERGAN, Dr

CONTACT

ifergan.gabriel@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 19, 2024

Study Start

February 28, 2024

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2031

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)