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

NCT05073510 | Completed Results

• 1 other identifier: BVE-01
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 4

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).

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; PAD; Arterial duplex

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determination of Presence or Absence of Significant PAD With BVE and ABPI

  1 day

• Number and Risk-classification of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  1 day

Other Outcomes (3)

• Time Spent for Arterial Duplex, BVE and ABPI Vascular Assessment

  1 day

• Determination of Presence or Absence of Significant PAD With BVE by Vascular and Non-vascular Experts

  1 day

• BVE Non-diagnostic Rate

  1 day

Study Arms (1)

BlueDop Vascular Expert (BVE)

PAD assessment with BVE

Device: BVE

Interventions

BVE DEVICE

Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)

BlueDop Vascular Expert (BVE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BlueDop Medical LTD: lead
• AKRN Scientific Consulting, S.L.: collaborator

Study Sites (4)

Hospital Los Madroños

Brunete, Madrid, 28690, Spain

Location

Hospital de Manises

Manises, Valencia, 46940, Spain

Location

Clínica Universidad de Navarra

Madrid, 28027, Spain

Location

Hospital Doctor Peset

Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Dr. Patrick Kelly
• Organization: BlueDop Medical, Ltd.

patrick@bluedopmedical.co.uk

+1 605 521 9831

Study Officials

• José Ignacio Leal Lorenzo

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 11, 2021
• Study Start: October 11, 2021
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)