Aneurysm, Abdominal AorticUltra_EvarNCT04196543
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
A study testing écho-doppler with ultrasonar Sonovue® injection in people with Aneurysm, Abdominal Aortic, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Abdominal Aortic
- What is being tested?
- écho-doppler with ultrasonar Sonovue® injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2020to 10 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Aneurysm, Abdominal Aortic
- Being tested
- écho-doppler with ultrasonar Sonovue® injection
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
écho-doppler with ultrasonar Sonovue® injectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| écho-doppler with ultrasonar Sonovue® injection | Experimental | Not described Receives: Other: écho-doppler with ultrasonar Sonovue® injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative
Measured: 1 day
detection of endoleaks after PCUS injection in immediate post-operative
Measured: 1 day
measurement of anterior-posterior diameters of endoleaks after PCUS injection in immediate post-operative
Measured: 1 day
Secondary outcomes (4)
Description of endoleaks after PCUS injection in immediate post-operative
Measured: 1 day
Description of exit doors of heart after PCUS injection in immediate post-operative
Measured: 1 day
Description of their flows after PCUS injection in immediate post-operative
Measured: 1 day
Description of maximum circulatory speeds after PCUS injection in immediate post-operative
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start28 Feb 2020
- Primary completion10 Dec 2021
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aneurysm, Abdominal AorticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal GIORDANA, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196543
- Sponsor's protocol ID
- 19-AOI-05
- Acronym
- Ultra_Evar
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2019
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 1999868Manning 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.
PubMed 19631858Bredahl 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.
PubMed 28131537Amrani S, Eveilleau K, Fassbender V, Obeid H, Abi-Nasr I, Giordana P, Hallab M, Leftheriotis G. Assessment of the systolic rise time by photoplethysmography in peripheral arterial diseases: a comparative study with ultrasound Doppler. Eur Heart J Open. 2022 Apr 28;2(3):oeac032. doi: 10.1093/ehjopen/oeac032. eCollection 2022 May.
PubMed 35919340
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04196543
- Acronym / sponsor ID
- Ultra_Evar / 19-AOI-05
- Conditions
- Aneurysm, Abdominal Aortic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| écho-doppler with ultrasonar Sonovue® injection | Experimental | Other: écho-doppler with ultrasonar Sonovue® injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| écho-doppler with ultrasonar Sonovue® injectionDuring 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. | Other | écho-doppler with ultrasonar Sonovue® injection |
Primary outcome
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
4 secondary outcomes
Description of endoleaks after PCUS injection in immediate post-operative
Time frame: 1 day
Description of exit doors of heart after PCUS injection in immediate post-operative
Time frame: 1 day
Description of their flows after PCUS injection in immediate post-operative
Time frame: 1 day
Description of maximum circulatory speeds after PCUS injection in immediate post-operative
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background: PubMed 1999868Johnston 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.
- Background: PubMed 19631858Manning 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.
- Background: PubMed 28131537Bredahl 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 publication: PubMed 35919340Amrani S, Eveilleau K, Fassbender V, Obeid H, Abi-Nasr I, Giordana P, Hallab M, Leftheriotis G. Assessment of the systolic rise time by photoplethysmography in peripheral arterial diseases: a comparative study with ultrasound Doppler. Eur Heart J Open. 2022 Apr 28;2(3):oeac032. doi: 10.1093/ehjopen/oeac032. eCollection 2022 May.
- Individual participant dataSharing planned: No
Related trials for Aneurysm, Abdominal Aortic
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal GIORDANA, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing écho-doppler with ultrasonar Sonovue® injection in people with Aneurysm, Abdominal Aortic, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04196543, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.