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 (Ultra_Evar)
Primary Purpose
Aneurysm, Abdominal Aortic
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
écho-doppler with ultrasonar Sonovue® injection
Sponsored by
About this trial
This is an interventional other trial for Aneurysm, Abdominal Aortic
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.
Sites / Locations
- University Hospital of Nice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
écho-doppler with ultrasonar Sonovue® injection
Arm Description
Outcomes
Primary Outcome Measures
measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative
detection of endoleaks after PCUS injection in immediate post-operative
measurement of anterior-posterior diameters of endoleaks after PCUS injection in immediate post-operative
Secondary Outcome Measures
Description of endoleaks after PCUS injection in immediate post-operative
Description of exit doors of heart after PCUS injection in immediate post-operative
Description of their flows after PCUS injection in immediate post-operative
Description of maximum circulatory speeds after PCUS injection in immediate post-operative
Full Information
NCT ID
NCT04196543
First Posted
November 13, 2019
Last Updated
July 20, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04196543
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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
December 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm, Abdominal Aortic
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
écho-doppler with ultrasonar Sonovue® injection
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
écho-doppler with ultrasonar Sonovue® injection
Intervention Description
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 Outcome Measure Information:
Title
measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative
Time Frame
1 day
Title
detection of endoleaks after PCUS injection in immediate post-operative
Time Frame
1 day
Title
measurement of anterior-posterior diameters of endoleaks after PCUS injection in immediate post-operative
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Description of endoleaks after PCUS injection in immediate post-operative
Time Frame
1 day
Title
Description of exit doors of heart after PCUS injection in immediate post-operative
Time Frame
1 day
Title
Description of their flows after PCUS injection in immediate post-operative
Time Frame
1 day
Title
Description of maximum circulatory speeds after PCUS injection in immediate post-operative
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal GIORDANA, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Nice
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
1999868
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.
Results Reference
background
PubMed Identifier
19631858
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.
Results Reference
background
PubMed Identifier
28131537
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.
Results Reference
background
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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
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