Peripheral Arterial DiseaseEchoPIV in SFANCT04934501
Blood Flow Quantification Near Stented SFA Lesions Using Ultrasound Velocimetry
An observational study of Peripheral Arterial Disease, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Peripheral arterial disease (PAD) in the lower extremity is the third leading cause of atherosclerotic cardiovascular morbidity. Endovascular treatment has become the principal surgical strategy in femoro-popliteal lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- High-frame-rate contrast-enhanced ultrasound measurements (echoPIV) and Computed tomography angiography (CTA) scan
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Aug 2018to 30 Aug 2019
- 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: Patients with peripheral arterial disease who have been treated with a stent placement in the superficial femoral artery.
Who may be able to join
- Scheduled endovascular treatment of a lesion in the SFA through placement of a bare metal or a covered stent
- A recently (<6 weeks) treated lesion in the SFA through placement of a bare metal or a covered stent
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
- Adult respiratory distress syndrome
- Severe pulmonary disease (e.g. COPD GOLD 3/4, adult respiratory distress syndrome)
Show all 14Show fewer
- Clinically unstable cardiac disease (recent or ongoing myocardial infarction, unstable angina at rest, recent percutaneous coronary intervention, clinically worsening cardiac symptoms, severe cardiac arrythmia'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 thrombosis
- Congestive heart failure (class III or IV)
- Hypersensitivity to iodinated contrast media
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Ultrasound Particle Image Velocimetry to Quantify Flow Near Stented SFA Lesions
Peripheral arterial disease (PAD) in the lower extremity is the third leading cause of atherosclerotic cardiovascular morbidity. Endovascular treatment has become the principal surgical strategy in femoro-popliteal lesions. Stent placement induces significant changes in the arterial geometry and thereby in the hemodynamic environment. Visualization of local blood flow patterns (around stents) is challenging, but clinically relevant. Blood flow has a significant influence on the development of atherosclerosis and therefore stent patency. In vivo blood flow characterization might enable the recognition, prediction and explanation of (in-stent) restenosis. This study will therefore aim to investigate the feasibility of a novel ultrasound technique (echoPIV) to quantify spatiotemporal blood flow near stented femoral artery lesions. Furthermore, the blood flow information obtained during the echoPIV measurements will be used as patient-specific boundary conditions in a computational fluid dynamics (CFD) simulation. The tested hypothesis is that blood flow quantification using echoPIV is feasible in and around stents in the femoral artery and that it will improve CFD simulations.
- Conditions
- Peripheral Arterial Disease
- Being tested
- High-frame-rate contrast-enhanced ultrasound measurements (echoPIV), Computed tomography angiography (CTA) scan
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frame-rate contrast-enhanced ultrasound measurements (echoPIV)Diagnostic test
Patients will undergo high-frame-rate contrast-enhanced ultrasound measurements, within 6 to 8 weeks after the endovascular procedure, at the vascular center of Rijnstate hospital. Prior to these measurements a venous cannula will be placed to ensure venous access for the contrast administration.
Computed tomography angiography (CTA) scanDiagnostic test
Patients will undergo a CTA scan of the lower extremities at the Radiology dept. of Rijnstate hospital the same day as the echoPIV measurements. This CTA scan serves as a reference for the vessel geometry and stent location.
| Study group | Role | What they receive |
|---|---|---|
| PAD patients | The entire cohort exists of patients recently treated with an endovascular stent placement in the superficial femoral artery (SFA). Receives: Diagnostic Test: High-frame-rate contrast-enhanced ultrasound measurements (echoPIV); Diagnostic Test: Computed tomography angiography (CTA) scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment vector velocity fields
Vector velocity fields derived from the echoPIV data will be used to calculate and visualize the velocity profile. In order to answer the question regarding feasibility of echoPIV the quality of the vector velocity fields will be assessed using three different metrics of which the first one is a qualitative assessment by different observers. Recordings of the contrast-enhanced ultrasound with an overlay of the vector velocity profiles will be reviewed on different topics following a scoring rubrics.
Measured: 6 to 8 weeks after the procedure (stent placement of SFA)
Contrast-to-background ratio
The contrast-to-background ratio (CBR) is the second metric to assess the outcomes of the echoPIV measurements. The CBR is a quantitative measure for the contrast levels and therefore for the quality of the contrast-enhanced US image. The higher the CBR level (in dB) the higher the intensity of the contrast which is needed for sufficient PIV analysis.
Measured: 6 to 8 weeks after the procedure (stent placement of SFA)
Vector correlation
The vector correlation is the third metric to assess the outcomes of the echoPIV measurements. The vector correlation demonstrates the tracking performance of the PIV algorithm. The vector correlation provides a unitless value between 0 and 1 in which 0 indicates poor tracking of the microbubble contrast and 1 indicates perfect tracking of the microbubble contrast.
Measured: 6 to 8 weeks after the procedure (stent placement of SFA)
Secondary outcomes (3)
Vorticity
Multiple blood flow parameters will be derived from the echoPIV data. The first one is the vorticity, or the curl of the velocity. The vorticity represents the rotation of particles inside the flow field. This measure can potentially be used to define regions with disturbed blood flow, as a high value (in rad/s) indicates the occurence of a recirculation.
Measured: 6 to 8 weeks after the procedure (stent placement of SFA)
Vector complexity
The second blood flow parameters derived from the echoPIV data is the vector complexity. Vector complexity is a measure of multi-directional flow, ranging from 0 till 1. a value of 1 means complex flow with all velocity vectors pointing in all directions, whereas a value of 0 means laminar flow with all velocity vectors pointing in the same direction. This measure can potentially be used to indicate regions with disturbed blood flow.
Measured: 6 to 8 weeks after the procedure (stent placement of SFA)
Correlation echoPIV and CFD
Velocity profiles obtained with echoPIV will be compared to outcomes of a computational fluid dynamics (CFD) simulation model of the femoral artery. Multiple points along the imaged vessel will be selected in both the echoPIV and the CFD data to extract the temporal velocity profile. This profile will be compared point-by-point after which the correlation between both outcomes/techniques will be obtained.
Measured: 6 to 8 weeks after the procedure (stent placement of SFA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start8 Aug 2018
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel MPJ Reijnen, PhD, Principal investigator, Dept. of Surgery, Rijnstate Hospital Arnhem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934501
- Sponsor's protocol ID
- 2018-1206
- Acronym
- EchoPIV in SFA
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Helvert M, Engelhard S, Voorneveld J, van der Vee M, Bosch JG, Versluis M, Groot Jebbink E, Reijnen MMPJ. High-frame-rate contrast-enhanced ultrasound particle image velocimetry in patients with a stented superficial femoral artery: a feasibility study. Eur Radiol Exp. 2022 Jul 6;6(1):32. doi: 10.1186/s41747-022-00278-w.
PubMed 35790584
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Ultrasound Particle Image Velocimetry to Quantify Flow Near Stented SFA Lesions
- ClinicalTrials.gov ID
- NCT04934501
- Acronym / sponsor ID
- EchoPIV in SFA / 2018-1206
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 22 Jun 2021 (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.
Peripheral arterial disease (PAD) in the lower extremity is the third leading cause of atherosclerotic cardiovascular morbidity. Endovascular treatment has become the principal surgical strategy in femoro-popliteal lesions. Stent placement induces significant changes in the arterial geometry and thereby in the hemodynamic environment. Visualization of local blood flow patterns (around stents) is challenging, but clinically relevant. Blood flow has a significant influence on the development of atherosclerosis and therefore stent patency. In vivo blood flow characterization might enable the recognition, prediction and explanation of (in-stent) restenosis. This study will therefore aim to investigate the feasibility of a novel ultrasound technique (echoPIV) to quantify spatiotemporal blood flow near stented femoral artery lesions. Furthermore, the blood flow information obtained during the echoPIV measurements will be used as patient-specific boundary conditions in a computational fluid dynamics (CFD) simulation. The tested hypothesis is that blood flow quantification using echoPIV is feasible in and around stents in the femoral artery and that it will improve CFD simulations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAD patients | – | Diagnostic Test: High-frame-rate contrast-enhanced ultrasound measurements (echoPIV), Diagnostic Test: Computed tomography angiography (CTA) scanThe entire cohort exists of patients recently treated with an endovascular stent placement in the superficial femoral artery (SFA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peripheral arterial disease who have been treated with a stent placement in the superficial femoral artery.
Key inclusion criteria (2 listed)
- Scheduled endovascular treatment of a lesion in the SFA through placement of a bare metal or a covered stent
- A recently (<6 weeks) treated lesion in the SFA through placement of a bare metal or a covered stent
Key exclusion criteria (14 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
- 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 |
|---|---|---|
| High-frame-rate contrast-enhanced ultrasound measurements (echoPIV)Patients will undergo high-frame-rate contrast-enhanced ultrasound measurements, within 6 to 8 weeks after the endovascular procedure, at the vascular center of Rijnstate hospital. Prior to these measurements a venous cannula will be placed to ensure venous access for the contrast administration. | Diagnostic test | PAD patients |
| Computed tomography angiography (CTA) scanPatients will undergo a CTA scan of the lower extremities at the Radiology dept. of Rijnstate hospital the same day as the echoPIV measurements. This CTA scan serves as a reference for the vessel geometry and stent location. | Diagnostic test | PAD patients |
Primary outcome
Qualitative assessment vector velocity fields
Time frame: 6 to 8 weeks after the procedure (stent placement of SFA)
Vector velocity fields derived from the echoPIV data will be used to calculate and visualize the velocity profile. In order to answer the question regarding feasibility of echoPIV the quality of the vector velocity fields will be assessed using three different metrics of which the first one is a qualitative assessment by different observers. Recordings of the contrast-enhanced ultrasound with an overlay of the vector velocity profiles will be reviewed on different topics following a scoring rubrics.
Contrast-to-background ratio
Time frame: 6 to 8 weeks after the procedure (stent placement of SFA)
The contrast-to-background ratio (CBR) is the second metric to assess the outcomes of the echoPIV measurements. The CBR is a quantitative measure for the contrast levels and therefore for the quality of the contrast-enhanced US image. The higher the CBR level (in dB) the higher the intensity of the contrast which is needed for sufficient PIV analysis.
Vector correlation
Time frame: 6 to 8 weeks after the procedure (stent placement of SFA)
The vector correlation is the third metric to assess the outcomes of the echoPIV measurements. The vector correlation demonstrates the tracking performance of the PIV algorithm. The vector correlation provides a unitless value between 0 and 1 in which 0 indicates poor tracking of the microbubble contrast and 1 indicates perfect tracking of the microbubble contrast.
3 secondary outcomes
Vorticity
Time frame: 6 to 8 weeks after the procedure (stent placement of SFA)
Vector complexity
Time frame: 6 to 8 weeks after the procedure (stent placement of SFA)
Correlation echoPIV and CFD
Time frame: 6 to 8 weeks after the procedure (stent placement of SFA)
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 22 Jun 2021.
- Derived from this study: PubMed 35790584van Helvert M, Engelhard S, Voorneveld J, van der Vee M, Bosch JG, Versluis M, Groot Jebbink E, Reijnen MMPJ. High-frame-rate contrast-enhanced ultrasound particle image velocimetry in patients with a stented superficial femoral artery: a feasibility study. Eur Radiol Exp. 2022 Jul 6;6(1):32. doi: 10.1186/s41747-022-00278-w.
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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 MPJ Reijnen, PhD principal investigator
Dept. of Surgery, Rijnstate Hospital Arnhem
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 Peripheral Arterial Disease, 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 2 inclusion and 14 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 22 Jun 2021. 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?
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?
Qualitative assessment vector velocity fields (time frame: 6 to 8 weeks after the procedure (stent placement of SFA)). 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 NCT04934501, which also lists 1 linked publication.
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 22 Jun 2021.