Clinical Trials Directory

Trials / Completed

CompletedNCT04196543

Interest of a Post-operative Ultrasound With Systematic Use of Ultrasonic Contrast in the Follow-up of Aortic Endoprosthesis: Prospective Study at the University Hospital of Nice

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Centre Hospitalier Universitaire de Nice · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a prospective study conducted on a population with an aortic endoprosthesis in the context of an abdominal aortic aneurysm. The study's objective is to standardize the ultrasound methodology in the monitoring of aortic endoprosthesis in immediate post-operative care by comparing the results with CT-scan (gold standard). To improve ultrasound methodology, the investigators propose to use the VESMA protocol for ultrasound diameter measurement at four incidences. In addition, the use of ultrasonic contrast agents increases the accuracy of vascular structures, the quality of the ultrasound blood flow image and the duration of signal enhancement. This makes it possible to visualize small gauge vessels and those with slow flows. In this way, the investigators could improve the ultrasound technique for measuring aneurysm bag diameters and endoleak detection. Moreover, the toxicity of iodinated contrast agents is the third cause of acute renal failure in hospitalized patients and is all the more frequent when the investigators increase injections. Improving the quality of ultrasound investigations for the monitoring of aortic endoprosthesis would therefore allow us to reduce the number of CT-scan performed in this population and thus reduce irradiation and the injection of nephrotoxic products. Thereby, the investigators would like to integrate the technique into the systematic follow-up of patients who have benefited from the placement of an aortic endoprosthesis by replacing the CT-scan.

Conditions

Interventions

TypeNameDescription
OTHERécho-doppler with ultrasonar Sonovue® injectionDuring this unique visit they will benefit from 2 imaging exams performed by two different operators: * Echo-doppler without "standard method" contrast injection (common practice) * An echo-doppler with Sonovue® ultrasound injection "Ultra\_evar method" (2.5 ml bolus 2-3 seconds) During this examination, the endoprosthesis and the aneurysm sac will be scanned according to the 4 incidences described above in order to objective whether or not there is a endoleak. The patient then performs the control CT-scan prior to discharge from hospital. The results of the medical imaging exams will be communicated to them before the hospital discharge, once the CT-scan has been performed. A cross-review of the studies will be performed later.

Timeline

Start date
2020-02-28
Primary completion
2021-12-10
Completion
2022-12-10
First posted
2019-12-12
Last updated
2026-03-24

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04196543. Inclusion in this directory is not an endorsement.