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

Last updated: November 11, 2024
Sponsor: BlueDop Medical LTD
Overall Status: Completed

Phase

N/A

Condition

Vascular Diseases

Claudication

Peripheral Arterial Occlusive Disease

Treatment

BVE

Clinical Study ID

NCT05073510
BVE-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject must provide written informed consent prior to any clinical investigationrelated procedure.

  2. At least 18 years of age.

  3. Referred for duplex ultrasound of the lower limb (s) with suspected or previoushistory 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

Exclusion Criteria:

  1. Subject is currently participating in another clinical investigation or hasparticipated in another clinical investigation in the past 30 days prior to thestart of the present study;

  2. Pregnant or nursing subjects and those who plan pregnancy during the clinicalinvestigation follow-up period

  3. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-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 thestudied arteries

Study Design

Total Participants: 187
Treatment Group(s): 1
Primary Treatment: BVE
Phase:
Study Start date:
October 11, 2021
Estimated Completion Date:
September 11, 2023

Study 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.

Connect with a study center

  • Hospital Los Madroños

    Brunete, Madrid 28690
    Spain

    Site Not Available

  • Hospital de Manises

    Manises, Valencia 46940
    Spain

    Site Not Available

  • Clínica Universidad de Navarra

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital Doctor Peset

    Valencia, 46017
    Spain

    Site Not Available

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