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NCT Number: NCT04196543

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

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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Key information

Conditions

Aneurysm, Abdominal Aortic Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Nice

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

écho-doppler with ultrasonar Sonovue® injection

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.

Primary outcomes

  1. measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative

    Time frame: 1 day

  2. detection of endoleaks after PCUS injection in immediate post-operative

    Time frame: 1 day

  3. measurement of anterior-posterior diameters of endoleaks after PCUS injection in immediate post-operative

    Time frame: 1 day

Secondary outcomes

  1. Description of endoleaks after PCUS injection in immediate post-operative

    Time frame: 1 day

  2. Description of exit doors of heart after PCUS injection in immediate post-operative

    Time frame: 1 day

  3. Description of their flows after PCUS injection in immediate post-operative

    Time frame: 1 day

  4. Description of maximum circulatory speeds after PCUS injection in immediate post-operative

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: Ultra_Evar

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 12, 2019
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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