Abdominal AneurysmAAA-VFINCT05841524
Vector Velocity Imaging in AAA Patients
An observational study of Abdominal Aneurysm and Thrombus, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The goal of this observational study is to perform an in vivo feasibility study using real time (3D) ultrasound based vector flow imaging in 10 AAA patients (5 with intraluminal thrombus and 5 without intraluminal thrombus). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aneurysm, Thrombus
- What is being tested?
- Vector flow imaging measurement
- How many people
- 14 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients diagnosed with an AAA. Both with and without intraluminal thrombus present.
Who may be able to join
- Diagnosed with AAA
- AAA diameter below treatment threshold of 5.5 cm
Who cannot join
- Hypersensitivity to the active substance(s) or any of the excipients in Sonovue
- 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.)
Show all 10Show fewer
- Prosthetic valves
- Loss of renal function (GFR < 31 ml/min), end-stage renal disease
- End-stage liver disease
- Sepsis
Trial locations and contacts
1 site in 1 country.
Norway1 site
St. Olavs hospital, Trondheim University Hospital
Trondheim, Trøndelag, 3250
About this study
Official title: Thrombus Formation Prediction in Abdominal Aneurysms Using Vector Flow Imaging
The goal of this observational study is to perform an in vivo feasibility study using real time (3D) ultrasound based vector flow imaging in 10 AAA patients (5 with intraluminal thrombus and 5 without intraluminal thrombus). Furthermore, the investigators will investigate the added value of contrast microbubbles in these high framerate, plane wave ultrasound measurements.
Included patients will undergo ultrasound scanning of their AAA, using multiple ultrasound sequences. Sequences will be tested with and without the addition of ultrasound contrast microbubbles.
Read the detailed description
Currently a AAA diameter > 5.5 cm is the cut-off for treatment with the rationale that rupture risk outweighs risk of surgery at that point. Although in large cohorts such thresholds adequately reflect the repair indication, they fail in case of patient-specific decision-making. This is reflected by the fact that both small AAA rupture and large AAA's have been documented to be stable. Moreover, recently introduced biomechanical parameters show promising results with respect to improved rupture risk prediction. A key parameter is intraluminal thrombus (ILT) formation at the vessel wall, which is observed in 75% of AAA's. Recent work has shown ILT to be promoting rupture risk, outweighing its protective effect by reducing wall stress. An explanation lies in the fact that the vessel wall is primarily oxygenated due to luminal oxygen diffusion and ILT decreases oxygen supply to the AAA wall by as much as 95%. This, in turn, leads to hypoxia, inflammation and vessel wall weakening, promoting AAA rupture. Others have also shown that small AAA's (< 6 cm) that ruptured have a significantly higher volume percentage of ILT. Biomechanics behind the formation of ILT indicate that aneurysmal blood flow plays a role, in combination with the complex and patient-specific AAA geometry, inducing blood flow perturbations, e.g. vortices and stagnation zones. These local blood flow perturbations facilitate platelet adhesion and ILT formation in regions of slow and stagnant flow, in turn increasing AAA growth and the associated rupture risk. This project is a first step to quantify in vivo AAA blood flow, using high frame rate ultrasound techniques, to perform both better risk stratification and risk management.
Conventional color Doppler imaging is performed using focused ultrasound beams, which limits the achievable frame rates to approximately 25 frames per second (fps). Recent developments in computer hardware and software has enabled a shift towards unfocused imaging, where anatomical ultrasound images can be made using only a single unfocused ultrasound pulse. With the new technology, the frame rate limit is suddenly increased by a factor of 500, which results in increased flexibility when designing imaging sequences. Extremely high frame rates can now be traded for increased complexity, enabling new information to be obtained.
In this project, the investigators will use continuous, high frame rate, ECG gated, 3D slice acquisition to quantify blood flow at the inflow of the aneurysm. This will result in a vector flow imaging dataset, including the through plane component. The received signal is based on the in vivo scattering properties of blood. However, the technique might benefit from the addition of ultrasound contrast agents, therefore a second set of measurements will be obtained after intravenous injection of a contrast agent (SonoVue).
The hypothesis is that high frame rate 3D ultrasound can be used to image aneurysm blood flow. From these measurements the investigators expect that travel distance analysis shows different outcomes between AAA patients with and without intraluminal thrombus. In turn this is another piece of the puzzle to stratify patients having a higher risk of aneurysm rupture.
- Conditions
- Abdominal Aneurysm, Thrombus
- Being tested
- Vector flow imaging measurement
- Medical subject headings
- Aortic Aneurysm, Abdominal, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vector flow imaging measurementDiagnostic test
Ultrasound measurement, using high framerate measurement techniques.
| Study group | Role | What they receive |
|---|---|---|
| AAA patients, without intraluminal thrombus | patients diagnosed with an abdominal aneurysm, with a diameter below the treatment threshold of 5.5 cm and without intraluminal thrombus. Receives: Diagnostic Test: Vector flow imaging measurement | |
| AAA patients, with intraluminal thrombus | patients diagnosed with an abdominal aneurysm, with a diameter below the treatment threshold of 5.5 cm and with intraluminal thrombus. Receives: Diagnostic Test: Vector flow imaging measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility scoring for obtaining blood flow measurements in the AAA
Scoring of the obtained data will be performed by a group of 5 experts
Measured: Through study completion, an average 6 months
Secondary outcomes (1)
Additional value of microbubble contrast injections on signal to noise ratio
Measurements will be performed with and without contrast, added value on signal to noise ratio will be investigated.
Measured: Through study completion, an average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Apr 2023
- Primary completion30 Dec 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University of Twente
- Responsible party
- Sponsor
- Investigators
- Arne Seternes, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841524
- Sponsor's protocol ID
- 238649
- Acronym
- AAA-VFI
- Status last verified
- Jul 2026
- First submitted
- 12 Apr 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombus Formation Prediction in Abdominal Aneurysms Using Vector Flow Imaging
- ClinicalTrials.gov ID
- NCT05841524
- Acronym / sponsor ID
- AAA-VFI / 238649
- Conditions
- Abdominal Aneurysm, Thrombus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University of Twente
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 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.
The goal of this observational study is to perform an in vivo feasibility study using real time (3D) ultrasound based vector flow imaging in 10 AAA patients (5 with intraluminal thrombus and 5 without intraluminal thrombus). Furthermore, the investigators will investigate the added value of contrast microbubbles in these high framerate, plane wave ultrasound measurements.
Included patients will undergo ultrasound scanning of their AAA, using multiple ultrasound sequences. Sequences will be tested with and without the addition of ultrasound contrast microbubbles.
Detailed description
Currently a AAA diameter > 5.5 cm is the cut-off for treatment with the rationale that rupture risk outweighs risk of surgery at that point. Although in large cohorts such thresholds adequately reflect the repair indication, they fail in case of patient-specific decision-making. This is reflected by the fact that both small AAA rupture and large AAA's have been documented to be stable. Moreover, recently introduced biomechanical parameters show promising results with respect to improved rupture risk prediction. A key parameter is intraluminal thrombus (ILT) formation at the vessel wall, which is observed in 75% of AAA's. Recent work has shown ILT to be promoting rupture risk, outweighing its protective effect by reducing wall stress. An explanation lies in the fact that the vessel wall is primarily oxygenated due to luminal oxygen diffusion and ILT decreases oxygen supply to the AAA wall by as much as 95%. This, in turn, leads to hypoxia, inflammation and vessel wall weakening, promoting AAA rupture. Others have also shown that small AAA's (< 6 cm) that ruptured have a significantly higher volume percentage of ILT. Biomechanics behind the formation of ILT indicate that aneurysmal blood flow plays a role, in combination with the complex and patient-specific AAA geometry, inducing blood flow perturbations, e.g. vortices and stagnation zones. These local blood flow perturbations facilitate platelet adhesion and ILT formation in regions of slow and stagnant flow, in turn increasing AAA growth and the associated rupture risk. This project is a first step to quantify in vivo AAA blood flow, using high frame rate ultrasound techniques, to perform both better risk stratification and risk management.
Conventional color Doppler imaging is performed using focused ultrasound beams, which limits the achievable frame rates to approximately 25 frames per second (fps). Recent developments in computer hardware and software has enabled a shift towards unfocused imaging, where anatomical ultrasound images can be made using only a single unfocused ultrasound pulse. With the new technology, the frame rate limit is suddenly increased by a factor of 500, which results in increased flexibility when designing imaging sequences. Extremely high frame rates can now be traded for increased complexity, enabling new information to be obtained.
In this project, the investigators will use continuous, high frame rate, ECG gated, 3D slice acquisition to quantify blood flow at the inflow of the aneurysm. This will result in a vector flow imaging dataset, including the through plane component. The received signal is based on the in vivo scattering properties of blood. However, the technique might benefit from the addition of ultrasound contrast agents, therefore a second set of measurements will be obtained after intravenous injection of a contrast agent (SonoVue).
The hypothesis is that high frame rate 3D ultrasound can be used to image aneurysm blood flow. From these measurements the investigators expect that travel distance analysis shows different outcomes between AAA patients with and without intraluminal thrombus. In turn this is another piece of the puzzle to stratify patients having a higher risk of aneurysm rupture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AAA patients, without intraluminal thrombus | – | Diagnostic Test: Vector flow imaging measurementpatients diagnosed with an abdominal aneurysm, with a diameter below the treatment threshold of 5.5 cm and without intraluminal thrombus. |
| AAA patients, with intraluminal thrombus | – | Diagnostic Test: Vector flow imaging measurementpatients diagnosed with an abdominal aneurysm, with a diameter below the treatment threshold of 5.5 cm and with intraluminal thrombus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with an AAA. Both with and without intraluminal thrombus present.
Key inclusion criteria (2 listed)
- Diagnosed with AAA
- AAA diameter below treatment threshold of 5.5 cm
Key exclusion criteria (10 listed)
- Hypersensitivity to the active substance(s) or any of the excipients in Sonovue
- 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)
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 |
|---|---|---|
| Vector flow imaging measurementUltrasound measurement, using high framerate measurement techniques. | Diagnostic test | AAA patients, with intraluminal thrombus, AAA patients, without intraluminal thrombus |
Primary outcome
Feasibility scoring for obtaining blood flow measurements in the AAA
Time frame: Through study completion, an average 6 months
Scoring of the obtained data will be performed by a group of 5 experts
1 secondary outcome
Additional value of microbubble contrast injections on signal to noise ratio
Time frame: Through study completion, an average 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- 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.
Arne Seternes principal investigator
St. Olavs Hospital
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 Aneurysm and Thrombus, run by St. Olavs Hospital at 1 site in Norway.
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 2 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility scoring for obtaining blood flow measurements in the AAA (time frame: Through study completion, an average 6 months). 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 21 Jul 2026.