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Clinical Trials/NCT04196543
NCT04196543
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country40 target enrollmentFebruary 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aneurysm, Abdominal Aortic
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
40
Locations
1
Primary Endpoint
measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2020
End Date
December 10, 2022
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 1 day

detection of endoleaks after PCUS injection in immediate post-operative

Time Frame: 1 day

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

Time Frame: 1 day

Secondary Outcomes

  • Description of endoleaks after PCUS injection in immediate post-operative(1 day)
  • Description of exit doors of heart after PCUS injection in immediate post-operative(1 day)
  • Description of their flows after PCUS injection in immediate post-operative(1 day)
  • Description of maximum circulatory speeds after PCUS injection in immediate post-operative(1 day)

Study Sites (1)

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