Skip to content

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

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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04196543
Acronym
Ultra_Evar
Enrollment
40
Registered
2019-12-12
Start date
2020-02-28
Completion date
2022-12-10
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm, Abdominal Aortic

Brief 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.

Interventions

OTHERécho-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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative1 day
detection of endoleaks after PCUS injection in immediate post-operative1 day
measurement of anterior-posterior diameters of endoleaks after PCUS injection in immediate post-operative1 day

Secondary

MeasureTime frame
Description of endoleaks after PCUS injection in immediate post-operative1 day
Description of exit doors of heart after PCUS injection in immediate post-operative1 day
Description of their flows after PCUS injection in immediate post-operative1 day
Description of maximum circulatory speeds after PCUS injection in immediate post-operative1 day

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPascal GIORDANA, MD

Centre Hospitalier Universitaire de Nice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026