Lower Extremity Arterial DiseaseNCT05689190
Non-invasive Flow Measurements in Patients With Lower Extremity Arterial Disease (LEAD)
An observational study of Lower Extremity Arterial Disease, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
Trial summary
This concerns a study with patients who will undergo endovascular treatment. Blood flow will be measured by 2D Duplex Ultrasound. Contrast data will be collected that will be processed offline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Arterial Disease
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Apr 2023to 25 Feb 2026
- 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: A total of 30 patients that are referred to the Vascular Surgery outpatient clinic (department of Vascular Surgery) with PAD and an indication for a percutaneous transluminal angioplasty.
Who may be able to join
- Patients referred to the vascular surgery outpatient clinic (LUMC) with PAD
- Age ≥18 years
- Superficial femoral artery (SFA) stenosis (>70% occluded)
- Elective for a percutaneous transluminal angioplasty procedure
- Written informed consent
Who cannot join
- Contraindications to angiography, such as severe renal insufficiency (eGFR< 20)
- Non-correctable bleeding disorder.
Trial locations and contacts
1 site in 1 country.
About this study
This concerns a study with patients who will undergo endovascular treatment. Blood flow will be measured by 2D Duplex Ultrasound. Contrast data will be collected that will be processed offline.
- Conditions
- Lower Extremity Arterial Disease
- Keywords
- blood flow measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | Duplex ultrasound, angiogram, PTA intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood flow
Repeatability and correlation of angiographic hemodynamic measurements compared with the golden standard 2D duplex ultrasound.
Measured: performed during a regular PTA intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start25 Apr 2023
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
Why it stopped: The study was terminated early due to slower-than-anticipated participant enrollment. There were no safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Carla SP van Rijswijk, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689190
- Sponsor's protocol ID
- ICBE-S-000115
- Status last verified
- May 2026
- First submitted
- 9 Jan 2023
- Last updated
- 13 May 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Flow Measurements in Patients With Lower Extremity Arterial Disease (LEAD)
- ClinicalTrials.gov ID
- NCT05689190
- Acronym / sponsor ID
- ICBE-S-000115
- Conditions
- Lower Extremity Arterial Disease
- Keywords
- blood flow measurements
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to slower-than-anticipated participant enrollment. There were no safety concerns.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Leiden University Medical Center
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 19 Jan 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.
This concerns a study with patients who will undergo endovascular treatment. Blood flow will be measured by 2D Duplex Ultrasound. Contrast data will be collected that will be processed offline.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | –Duplex ultrasound, angiogram, PTA intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 30 patients that are referred to the Vascular Surgery outpatient clinic (department of Vascular Surgery) with PAD and an indication for a percutaneous transluminal angioplasty.
Key inclusion criteria (5 listed)
- Patients referred to the vascular surgery outpatient clinic (LUMC) with PAD
- Age ≥18 years
- Superficial femoral artery (SFA) stenosis (>70% occluded)
- Elective for a percutaneous transluminal angioplasty procedure
- Written informed consent
Key exclusion criteria (2 listed)
- Contraindications to angiography, such as severe renal insufficiency (eGFR< 20)
- Non-correctable bleeding disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
blood flow
Time frame: performed during a regular PTA intervention
Repeatability and correlation of angiographic hemodynamic measurements compared with the golden standard 2D duplex ultrasound.
Results and safety
The study was stopped early (reason given: The study was terminated early due to slower-than-anticipated participant enrollment. There were no safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 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.
Carla SP van Rijswijk principal investigator
Leiden University Medical Center
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 Lower Extremity Arterial Disease, run by Philips Clinical & Medical Affairs Global 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 13 May 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 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 was stopped early (reason given: The study was terminated early due to slower-than-anticipated participant enrollment. There were no safety concerns.). 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?
blood flow (time frame: performed during a regular PTA intervention). 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 13 May 2026.