Clinical trial 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysm, Abdominal Aortic
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.
* Person deprived of liberty by judicial or administrative decision.
* Person subject to legal protection.

Primary outcomes:
measure: measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative
timeFrame: 1 day
measure: detection of endoleaks after PCUS injection in immediate post-operative
timeFrame: 1 day
measure: measurement of anterior-posterior diameters of endoleaks after PCUS injection in immediate post-operative
timeFrame: 1 day
Secondary outcomes:
measure: Description of endoleaks after PCUS injection in immediate post-operative
timeFrame: 1 day
measure: Description of exit doors of heart after PCUS injection in immediate post-operative
timeFrame: 1 day
measure: Description of their flows after PCUS injection in immediate post-operative
timeFrame: 1 day
measure: Description of maximum circulatory speeds after PCUS injection in immediate post-operative
timeFrame: 1 day
Other outcomes:
Locations:
city: Nice
country: France
facility: University Hospital of Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Pascal GIORDANA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnston KW, Rutherford RB, Tilson MD, Shah DM, Hollier L, Stanley JC. Suggested standards for reporting on arterial aneurysms. Subcommittee on Reporting Standards for Arterial Aneurysms, Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery and North American Chapter, International Society for Cardiovascular Surgery. J Vasc Surg. 1991 Mar;13(3):452-8. doi: 10.1067/mva.1991.26737.
citation: Manning BJ, Kristmundsson T, Sonesson B, Resch T. Abdominal aortic aneurysm diameter: a comparison of ultrasound measurements with those from standard and three-dimensional computed tomography reconstruction. J Vasc Surg. 2009 Aug;50(2):263-8. doi: 10.1016/j.jvs.2009.02.243.
citation: Bredahl KK. Response to commentary on "Re: Contrast Enhanced Ultrasound can Replace Computed Tomography Angiography for Surveillance After Endovascular Aortic Aneurysm Repair". Eur J Vasc Endovasc Surg. 2017 Mar;53(3):446-447. doi: 10.1016/j.ejvs.2016.12.029. Epub 2017 Jan 26. No abstract available.