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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2022-12-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Aneurysm, Abdominal Aortic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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écho-doppler with ultrasonar Sonovue® injection

Group Type EXPERIMENTAL

écho-doppler with ultrasonar Sonovue® injection

Intervention Type OTHER

During 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.

Interventions

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écho-doppler with ultrasonar Sonovue® injection

During 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age.
* Abdominal aortic aneurysm treated with aortic stent.
* Signature of informed consent.
* Person affiliated or beneficiary of a social security scheme

Exclusion Criteria

* Hypersensitivity to sulphur hexafluoride or to these excipients (Macrogol 4000, Distearoylphosphatidylcholine, Dipalmitoylphosphatidylglycerol sodé, Palmitic acid).
* Right-left shunt patient
* Patient with severe pulmonary hypertension (pulmonary blood pressure \> 90 mm Hg),
* Patient with uncontrolled systemic hypertension
* Adult patients with respiratory distress syndrome.
* Dobutamine patient in patients with a pathology suggesting cardiac instability
* Hypercoagulation, recent thromboembolic accident
* Fenestrated aortic stent
* Pregnant or nursing woman.
* Severe heart failure.
* Person deprived of liberty by judicial or administrative decision.
* Person subject to legal protection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No