Abdominal Aortic Aneurysm3D US - EVARNCT05871515
3D Ultrasound of Abdominal Aortic Aneurysm Characteristics
An observational study of Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
AAA characteristics are traditionally measured with computed tomography angiography (CTA), however, three-dimensional ultrasound (3D US) is emerging as a novel imaging method for AAAs. With the use of a US contrast agent, the AAA thrombus can also be distinguished from the lumen on the 3D scans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- 3D ultrasound
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Dec 2022to Jan 2025
- Phase
- Observational
- 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
Study population: 20 subjects with an AAA who are up for EVAR treatment will be included. Participants will be recruited from the Rijnstate hospital.
Who may be able to join
- Unruptured infrarenal or juxtarenal abdominal aortic aneurysm (AAA);
- Scheduled for elective endovascular repair (EVAR);
- Preoperative CTA with iodine contrast available;
- Informed consent form understood and signed.
Who cannot join
- BMI>40 kg/m2
- Symptomatic AAA;
- Implanted pacemaker or ICD;
- Unable to hold breath for ≤7 seconds;
- Pregnant;
- Hypersensitivity to the active substance(s) or any of the excipients in Sonovue;
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- Known right-to-left cardiac shunt;
- Severe pulmonary hypertension (pulmonary artery pressure > 90mmHg);
- Uncontrolled systemic hypertension;
- Severe pulmonary disease (e.g. COPD GOLD 3 or 4, adult respiratory distress syndrome);
- Clinically unstable cardiac disease (recent, < 3 months, or ongoing myocardial infarction, unstable angina at rest, recent percutaneous coronary intervention, clinically worsening cardiac symptoms, severe cardiac arrhythmia's, endocarditis, etc.);
- Prosthetic valves;
- Loss of renal function (GFR < 31 mL/min), end-stage renal disease;
- End-stage liver disease;
- Sepsis;
- Hypercoagulable status, recent (< 3 months) thrombosis;
- Congestive heart failure (class III or IV);
- Psychiatric or other condition that may interfere with the study;
- Participating in another clinical study that interferes on the primary outcomes of this study;
- 3D US measurement of AAA is impossible because of bowel gasses or other causes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D Ultrasound of Abdominal Aortic Aneurysm Characteristics for Predicting Aneurysm Shrinkage After Endovascular Repair
AAA characteristics are traditionally measured with computed tomography angiography (CTA), however, three-dimensional ultrasound (3D US) is emerging as a novel imaging method for AAAs. With the use of a US contrast agent, the AAA thrombus can also be distinguished from the lumen on the 3D scans. This enables 3D visualization of the AAA and its thrombus without the need for harmful radiation and nephrotoxic contrast agents, as opposed to CTA. In in vitro measurements, 3D US has already been shown to have clinically acceptable error rate with AAA diameter and volume measurement. However, it is unclear whether this is also applicable to in vivo measurements. Therefore, the aim of this prospective study is to compare preoperative 3D US AAA characteristics as measured by 3D US with contrast enhancement (3D CEUS), 3D US without contrast enhancement (3D non-CEUS) and CTA.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- 3D ultrasound
- 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.
3D ultrasoundDevice
A 3D ultrasound is performed preoperatively to measure various aneurysm characteristics
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum AAA diameter (mm) as measured by 3D non-CEUS, 3D CEUS and CTA
For each imaging modality, the AAA and the lumen will be segmented in specialized segmentation software. Then a centerline will be computed through the lumen and perpendicular to this line, the AAA diameters are measured. From all these diameter measurements, the maximum AAA diameter will then be computed.
Measured: Preoperatively
AAA volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
For each imaging modality, the AAA will be segmented in specialized segmentation software and then the size of the volume will be computed.
Measured: Preoperatively
lumen volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
For each imaging modality, the lumen will be segmented in specialized segmentation software and then the size of the volume will be computed.
Measured: Preoperatively
thrombus thickness (mm) as measured by 3D non-CEUS, 3D CEUS and CTA
For each imaging modality, the thrombus will be segmented in specialized segmentation software and then the thrombus thickness will be computed.
Measured: Preoperatively
thrombus volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
For each imaging modality, the thrombus will be segmented in specialized segmentation software and then the size of the volume will be computed.
Measured: Preoperatively
Secondary outcomes (1)
Maximum AAA diameter change (mm) one-year after EVAR versus preoperative
Compare the maximum AAA diameter on preoperative imaging to the maximum AAA diameter on one-year imaging (within same modality).
Aneurysm growth is defined as a growth of 5 mm or more, aneurysm shrinkage is defined as a shrinkage of 5 mm or more and any aneurysm with a change of less then 5 mm is considered to be stable.
Measured: 1 year after EVAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start27 Dec 2022
- Primary completion13 Dec 2023
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Reijnen, prof. dr., Principal investigator, Rijnstate hospital, Arnhem, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871515
- Sponsor's protocol ID
- 2021-1929
- Other IDs
- NL81910.091.22
- Acronym
- 3D US - EVAR
- Status last verified
- Jan 2024
- First submitted
- 3 Apr 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Ultrasound of Abdominal Aortic Aneurysm Characteristics for Predicting Aneurysm Shrinkage After Endovascular Repair
- ClinicalTrials.gov ID
- NCT05871515
- Acronym / sponsor ID
- 3D US - EVAR / 2021-1929
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- Jan 2025 (estimated)
- First posted
- 23 May 2023 (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.
AAA characteristics are traditionally measured with computed tomography angiography (CTA), however, three-dimensional ultrasound (3D US) is emerging as a novel imaging method for AAAs. With the use of a US contrast agent, the AAA thrombus can also be distinguished from the lumen on the 3D scans. This enables 3D visualization of the AAA and its thrombus without the need for harmful radiation and nephrotoxic contrast agents, as opposed to CTA. In in vitro measurements, 3D US has already been shown to have clinically acceptable error rate with AAA diameter and volume measurement. However, it is unclear whether this is also applicable to in vivo measurements. Therefore, the aim of this prospective study is to compare preoperative 3D US AAA characteristics as measured by 3D US with contrast enhancement (3D CEUS), 3D US without contrast enhancement (3D non-CEUS) and CTA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 subjects with an AAA who are up for EVAR treatment will be included. Participants will be recruited from the Rijnstate hospital.
Key inclusion criteria (4 listed)
- Unruptured infrarenal or juxtarenal abdominal aortic aneurysm (AAA);
- Scheduled for elective endovascular repair (EVAR);
- Preoperative CTA with iodine contrast available;
- Informed consent form understood and signed.
Key exclusion criteria (20 listed)
- BMI>40 kg/m2
- Symptomatic AAA;
- Implanted pacemaker or ICD;
- Unable to hold breath for ≤7 seconds;
- Pregnant;
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 |
|---|---|---|
| 3D ultrasoundA 3D ultrasound is performed preoperatively to measure various aneurysm characteristics | Device | – |
Primary outcome
maximum AAA diameter (mm) as measured by 3D non-CEUS, 3D CEUS and CTA
Time frame: Preoperatively
For each imaging modality, the AAA and the lumen will be segmented in specialized segmentation software. Then a centerline will be computed through the lumen and perpendicular to this line, the AAA diameters are measured. From all these diameter measurements, the maximum AAA diameter will then be computed.
AAA volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
Time frame: Preoperatively
For each imaging modality, the AAA will be segmented in specialized segmentation software and then the size of the volume will be computed.
lumen volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
Time frame: Preoperatively
For each imaging modality, the lumen will be segmented in specialized segmentation software and then the size of the volume will be computed.
thrombus thickness (mm) as measured by 3D non-CEUS, 3D CEUS and CTA
Time frame: Preoperatively
For each imaging modality, the thrombus will be segmented in specialized segmentation software and then the thrombus thickness will be computed.
thrombus volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA
Time frame: Preoperatively
For each imaging modality, the thrombus will be segmented in specialized segmentation software and then the size of the volume will be computed.
1 secondary outcome
Maximum AAA diameter change (mm) one-year after EVAR versus preoperative
Time frame: 1 year after EVAR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Michel Reijnen, prof. dr. principal investigator
Rijnstate hospital, Arnhem, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
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 20 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: status not confirmed, as of the sponsor's last update on 1 Feb 2024. 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 Netherlands. 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?
Results are not available in the source record.
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?
maximum AAA diameter (mm) as measured by 3D non-CEUS, 3D CEUS and CTA (time frame: Preoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2024.