Clinical Evaluation of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease

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).

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: BVE

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.

• Study Type: Observational
• Enrollment (Anticipated): 188

Contacts and Locations

• Study Contact: Name: José Ignacio Leal Lorenzo; Phone Number: +34 625 587 795; Email: jleall@unav.es

Study Locations

• Spain
  • Madrid, Spain, 28027
    • Recruiting
    • Clinica Universidad de Navarra
    • Contact: José Ignacio Leal Lorenzo, MD
  • Valencia, Spain, 46017
    • Recruiting
    • Hospital Doctor Peset
    • Contact: Francisco Gómez Palonés, MD
  • Madrid
    • Brunete, Madrid, Spain, 28690
      • Recruiting
      • Hospital Los Madroños
      • Contact: Joaquín de Haro, MD
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Recruiting
      • Hospital de Manises
      • Contact: Vicente Molina Nácher, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for evaluation of PAD of the limbs when performed with duplex by a vascular specialist

Description

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 Artey (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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BlueDop Vascular Expert (BVE); PAD assessment with BVE	Device: BVE; Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 day
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.	1 day
BVE non-diagnostic rate	Number of patients and/or limbs that could not be assessed by BVE.	1 day

Collaborators and Investigators

• Sponsor: BlueDop Medical LTD
• Collaborators: AKRN Scientific Consulting, S.L.
• Investigators: Principal Investigator: José Ignacio Leal Lorenzo, Clinica Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: PAD; Peripheral Arterial Disease; Arterial duplex
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: BVE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No