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

Aneurysm, Abdominal Aortic Clinical Trial

— Ultra_Evar  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196543
• Other study ID #: 19-AOI-05
• Status: Completed
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: December 10, 2022

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 10, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Abdominal Aortic
• Aortic Aneurysm, Abdominal

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	University Hospital of Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative		1 day
Primary	detection of endoleaks after PCUS injection in immediate post-operative		1 day
Primary	measurement of anterior-posterior diameters of endoleaks after PCUS injection in immediate post-operative		1 day
Secondary	Description of endoleaks after PCUS injection in immediate post-operative		1 day
Secondary	Description of exit doors of heart after PCUS injection in immediate post-operative		1 day
Secondary	Description of their flows after PCUS injection in immediate post-operative		1 day
Secondary	Description of maximum circulatory speeds after PCUS injection in immediate post-operative		1 day