Peripheral Arterial Disease
Conditions
Keywords
Peripheral Arterial Disease, PAD, Arterial duplex
Brief 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).
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. 1. 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. 2. 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. 3. 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.
Interventions
DEVICEBVE
Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)
Sponsors
AKRN Scientific Consulting, S.L.
BlueDop Medical LTD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject must provide written informed consent prior to any clinical investigation related procedure. 2. At least 18 years of age. 3. Referred for duplex ultrasound of the lower limb (s) with suspected or previous history of peripheral arterial disease 4. Must have an ABPI performed as part of the assessment 5. Able to obtain a brachial cuff blood pressure reading 6. Must have a valid ankle duplex ultrasound measurement at the Posterior Tibial Artery (PTA) and Dorsalis Pedis Artery (DPA)
Exclusion criteria
1. 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; 2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period 3. 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; 4. Inability or refusal to give informed consent 5. Lower extremity wound or compromised skin of the legs that prevents access to the studied arteries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of Presence or Absence of Significant PAD With BVE and ABPI | 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 ABPI. Significant PAD is established when ABPI index is \<0.8. |
| Number and Risk-classification of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 1 day | Evaluation of BVE safety through the assessment of the risk and occurrence rates of AEs and SAEs |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time Spent for Arterial Duplex, BVE and ABPI Vascular Assessment | 1 day | Comparison of the time to perform a vascular assessment using arterial duplex, BVE, and ABPI (when available). |
| Determination of Presence or Absence of Significant PAD With BVE by Vascular and Non-vascular Experts | 1 day | Evaluation of clinical equivalence of BVE testing performed by staff specifically trained on BVE who are not vascular technologists/specialists compared to BVE testing performed by vascular technologists/specialists. |
| BVE Non-diagnostic Rate | 1 day | Number of patients and/or limbs that could not be assessed by BVE. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BlueDop Vascular Expert (BVE) PAD assessment with BVE
BVE: Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD) | 187 |
| Total | 187 |
Baseline characteristics
| Characteristic | BlueDop Vascular Expert (BVE) | — |
|---|---|---|
| Age, Continuous | 68.24 years STANDARD_DEVIATION 12.69 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Spain | 187 participants | — |
| Sex: Female, Male Female | 64 Participants | — |
| Sex: Female, Male Male | 123 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 187 |
| other Total, other adverse events | 0 / 187 |
| serious Total, serious adverse events | 0 / 187 |
Outcome results
Primary
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)
Time frame: 1 day
Population: ElP
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| BlueDop Vascular Expert (BVE) | Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex | False Negatives | 43 Limbs |
| BlueDop Vascular Expert (BVE) | Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex | True Positives | 62 Limbs |
| BlueDop Vascular Expert (BVE) | Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex | False Positives | 14 Limbs |
| BlueDop Vascular Expert (BVE) | Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex | True Negatives | 212 Limbs |
Secondary
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.
Time frame: 1 day
Population: ElP
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| BlueDop Vascular Expert (BVE) | Determination of Presence or Absence of Significant PAD With BVE and ABPI | True Positives | 62 Limbs |
| BlueDop Vascular Expert (BVE) | Determination of Presence or Absence of Significant PAD With BVE and ABPI | False Positives | 11 Limbs |
| BlueDop Vascular Expert (BVE) | Determination of Presence or Absence of Significant PAD With BVE and ABPI | True Negatives | 202 Limbs |
| BlueDop Vascular Expert (BVE) | Determination of Presence or Absence of Significant PAD With BVE and ABPI | False Negatives | 51 Limbs |
Secondary
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
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BlueDop Vascular Expert (BVE) | Number and Risk-classification of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 0 adverse events |
Other Pre-specified
BVE Non-diagnostic Rate
Number of patients and/or limbs that could not be assessed by BVE.
Time frame: 1 day
Population: This outcome was analyzed in the Enrollment population, not in the Eligible Population. The Eligible Population comprises the subset of enrolled patients who have at least one valid determination of PAD with both devices, and a limb without a valid PAD determination is considered analyzed if the other limb has a valid PAD determination. In the Enrollment Population we can find patients without any valid determination of PAD with BVE.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| BlueDop Vascular Expert (BVE) | BVE Non-diagnostic Rate | 74 Limbs |
Other Pre-specified
Determination of Presence or Absence of Significant PAD With BVE by Vascular and Non-vascular Experts
Evaluation of clinical equivalence of BVE testing performed by staff specifically trained on BVE who are not vascular technologists/specialists compared to BVE testing performed by vascular technologists/specialists.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BlueDop Vascular Expert (BVE) | Determination of Presence or Absence of Significant PAD With BVE by Vascular and Non-vascular Experts | 0.8798 Proportion of cases with agreement |
Other Pre-specified
Time Spent for Arterial Duplex, BVE and ABPI Vascular Assessment
Comparison of the time to perform a vascular assessment using arterial duplex, BVE, and ABPI (when available).
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BlueDop Vascular Expert (BVE) | Time Spent for Arterial Duplex, BVE and ABPI Vascular Assessment | 11.36 minutes | Standard Deviation 6.14 |
| Duplex | Time Spent for Arterial Duplex, BVE and ABPI Vascular Assessment | 16.90 minutes | Standard Deviation 6.57 |
| BVE-01 | Time Spent for Arterial Duplex, BVE and ABPI Vascular Assessment | 15.21 minutes | Standard Deviation 11.24 |
| ABPI Automated Measure | Time Spent for Arterial Duplex, BVE and ABPI Vascular Assessment | 11.39 minutes | Standard Deviation 3.35 |