Brief 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
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
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.
Study Type
Interventional
Primary Outcome
measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative
Secondary Outcome
Description of endoleaks after PCUS injection in immediate post-operative
Condition
Aneurysm, Abdominal Aortic
Intervention
écho-doppler with ultrasonar Sonovue® injection
Study Arms / Comparison Groups
écho-doppler with ultrasonar Sonovue® injection
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
40
Start Date
December 2019
Completion Date
December 2020
Primary Completion Date
December 2019
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pascal GIORDANA, MD, 04 92 03 77 16, [email protected]
Administrative Informations
NCT ID
NCT04196543
Organization ID
19-AOI-05
Responsible Party
Sponsor
Study Sponsor
Centre Hospitalier Universitaire de Nice
Study Sponsor
Pascal GIORDANA, MD, Principal Investigator, Centre Hospitalier Universitaire de Nice
Verification Date
November 2019