Peripheral Arterial DiseaseNCT05073510
Clinical Evaluation of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease
An observational study of Peripheral Arterial Disease, run by BlueDop Medical LTD at 4 sites in Spain.
Trial summary
This is a BlueDop Vascular Expert System (BVE) Post-Market Clinical Follow-Up (PMCF) study. The primary objective of the study is to assess the clinical applicability and diagnostic accuracy of the BVE device in subjects who require an arterial duplex test due to suspected peripheral arterial disease (PAD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- BVE
- Type of treatment
- Medical device
- How many people
- 187 participants
- Where
- 4 sitesSpain
- Study dates
- 11 Oct 2021to 11 Sep 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred for evaluation of PAD of the limbs when performed with duplex by a vascular specialist
Who may be able to join
- Subject must provide written informed consent prior to any clinical investigation related procedure.
- At least 18 years of age.
- Referred for duplex ultrasound of the lower limb (s) with suspected or previous history of peripheral arterial disease
- Must have an ABPI performed as part of the assessment
- Able to obtain a brachial cuff blood pressure reading
- Must have a valid ankle duplex ultrasound measurement at the Posterior Tibial Artery (PTA) and Dorsalis Pedis Artery (DPA)
Who cannot join
- Subject is currently participating in another clinical investigation or has participated in another clinical investigation in the past 30 days prior to the start of the present study;
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness;
- Inability or refusal to give informed consent
- Lower extremity wound or compromised skin of the legs that prevents access to the studied arteries
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Los Madroños
Brunete, Madrid, 28690
Clínica Universidad de Navarra
Madrid, 28027
Hospital de Manises
Manises, Valencia, 46940
Hospital Doctor Peset
Valencia, 46017
About this study
Official title: A Prospective, Multicenter, Nonrandomized, Open-label, Single-arm Study of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease
This is a BlueDop Vascular Expert System (BVE) Post-Market Clinical Follow-Up (PMCF) study. The primary objective of the study is to assess the clinical applicability and diagnostic accuracy of the BVE device in subjects who require an arterial duplex test due to suspected peripheral arterial disease (PAD).
Read the detailed description
The BVE device is intended to assess mean peripheral pressure, vascular reserve, Cuff free Ankle Brachial Index (ABIm), and assess the presence or absence of hemodynamically significant arterial disease. By converting Doppler shifts to a blood pressure measurement, BVE can be used to monitor PAD in a non-invasive manner without confounding by arterial calcification.
This is a post-market, interventional, prospective, multi-center, open-label, non-randomized, single-arm clinical investigation designed to evaluate the clinical equivalence of BVE to arterial Duplex in a group of patients referred for evaluation of PAD of the limbs when performed by a vascular specialist. Moreover, the evaluation of the clinical performance including inter-operator variability and BVE non-diagnostic rate will be also carried out as exploratory variables.
- Primary objective: Evaluate the clinical equivalence (assessment of accuracy) of BVE as binary result (either presence or absence of significant peripheral arterial disease) compared to arterial duplex ultrasound in a group of patients referred for evaluation of PAD of the lower limbs when performed by a vascular specialist.
- Secondary objectives: Evaluate the clinical equivalence (assessment of accuracy) of BVE as binary result (either presence or absence of significant peripheral arterial disease) compared to ankle brachial pressure index (ABPI) in a group of patients referred for evaluation of PAD of the lower limbs when performed by a vascular specialist. Assess the safety of the BVE device.
- Exploratory objectives:
Evaluation of the BVE System for clinical performance including time needed to perform BVE, inter-operator variability and number of BVE non-diagnostic tests.
- Conditions
- Peripheral Arterial Disease
- Being tested
- BVE
- Keywords
- Peripheral Arterial Disease, PAD, Arterial duplex
- 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.
BVEDevice
Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)
| Study group | Role | What they receive |
|---|---|---|
| BlueDop Vascular Expert (BVE) | PAD assessment with BVE Receives: Device: BVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex
Evaluation of clinical equivalence through a binary result (either presence or absence of significant PAD) in BVE compared to a binary summary of the arterial duplex.
Significant PAD is established with Duplex ultrasound when peak systolic velocity ratio (PSVR) is greater than 3 for any one level, or, if patients have multi-level disease, PSVR ≥ 2 at more than one level (i.e. sfa, pop)
Measured: 1 day
Secondary outcomes (2)
Determination of Presence or Absence of Significant PAD With BVE and ABPI
Evaluation of clinical equivalence through a binary result (either presence or absence of significant PAD) in BVE compared to a binary summary of ABPI.
Significant PAD is established when ABPI index is <0.8.
Measured: 1 day
Number and Risk-classification of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Evaluation of BVE safety through the assessment of the risk and occurrence rates of AEs and SAEs
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 posted11 Oct 2021
- Study start11 Oct 2021
- Primary completion11 Sep 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- BlueDop Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AKRN Scientific Consulting, S.L.
- Responsible party
- Sponsor
- Investigators
- José Ignacio Leal Lorenzo, Principal investigator, Clinica Universidad de Navarra, Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073510
- Sponsor's protocol ID
- BVE-01
- Status last verified
- Nov 2024
- First submitted
- 15 Sep 2021
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Nonrandomized, Open-label, Single-arm Study of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT05073510
- Acronym / sponsor ID
- BVE-01
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, PAD, Arterial duplex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- BlueDop Medical LTDIndustry (pharma, biotech, devices)
- Collaborators
- AKRN Scientific Consulting, S.L.
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Posted 27 Dec 2024
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 BlueDop Vascular Expert System (BVE) Post-Market Clinical Follow-Up (PMCF) study. The primary objective of the study is to assess the clinical applicability and diagnostic accuracy of the BVE device in subjects who require an arterial duplex test due to suspected peripheral arterial disease (PAD).
Detailed description
The BVE device is intended to assess mean peripheral pressure, vascular reserve, Cuff free Ankle Brachial Index (ABIm), and assess the presence or absence of hemodynamically significant arterial disease. By converting Doppler shifts to a blood pressure measurement, BVE can be used to monitor PAD in a non-invasive manner without confounding by arterial calcification.
This is a post-market, interventional, prospective, multi-center, open-label, non-randomized, single-arm clinical investigation designed to evaluate the clinical equivalence of BVE to arterial Duplex in a group of patients referred for evaluation of PAD of the limbs when performed by a vascular specialist. Moreover, the evaluation of the clinical performance including inter-operator variability and BVE non-diagnostic rate will be also carried out as exploratory variables.
- Primary objective: Evaluate the clinical equivalence (assessment of accuracy) of BVE as binary result (either presence or absence of significant peripheral arterial disease) compared to arterial duplex ultrasound in a group of patients referred for evaluation of PAD of the lower limbs when performed by a vascular specialist.
- Secondary objectives: Evaluate the clinical equivalence (assessment of accuracy) of BVE as binary result (either presence or absence of significant peripheral arterial disease) compared to ankle brachial pressure index (ABPI) in a group of patients referred for evaluation of PAD of the lower limbs when performed by a vascular specialist. Assess the safety of the BVE device.
- Exploratory objectives:
Evaluation of the BVE System for clinical performance including time needed to perform BVE, inter-operator variability and number of BVE non-diagnostic tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BlueDop Vascular Expert (BVE) | – | Device: BVEPAD assessment with BVE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for evaluation of PAD of the limbs when performed with duplex by a vascular specialist
Key inclusion criteria (6 listed)
- Subject must provide written informed consent prior to any clinical investigation related procedure.
- At least 18 years of age.
- Referred for duplex ultrasound of the lower limb (s) with suspected or previous history of peripheral arterial disease
- Must have an ABPI performed as part of the assessment
- Able to obtain a brachial cuff blood pressure reading
Key exclusion criteria (5 listed)
- Subject is currently participating in another clinical investigation or has participated in another clinical investigation in the past 30 days prior to the start of the present study;
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness;
- Inability or refusal to give informed consent
- Lower extremity wound or compromised skin of the legs that prevents access to the studied arteries
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 |
|---|---|---|
| BVEParticipants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD) | Device | BlueDop Vascular Expert (BVE) |
Primary outcome
Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex
Time frame: 1 day
Evaluation of clinical equivalence through a binary result (either presence or absence of significant PAD) in BVE compared to a binary summary of the arterial duplex. Significant PAD is established with Duplex ultrasound when peak systolic velocity ratio (PSVR) is greater than 3 for any one level, or, if patients have multi-level disease, PSVR ≥ 2 at more than one level (i.e. sfa, pop)
2 secondary outcomes
Determination of Presence or Absence of Significant PAD With BVE and ABPI
Time frame: 1 day
Number and Risk-classification of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
José Ignacio Leal Lorenzo principal investigator
Clinica Universidad de Navarra, Universidad de Navarra
4 sites 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 BlueDop Medical LTD at 4 sites in Spain.
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 6 inclusion and 5 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex (time frame: 1 day). 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 27 Dec 2024.