Clinical trial NCT05073510: Clinical Evaluation of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease
Official title: A Prospective, Multicenter, Nonrandomized, Open-label, Single-arm Study of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
PAD
Arterial duplex
Lead sponsor: BlueDop Medical LTD
Sponsor class: INDUSTRY
Collaborators: name: AKRN Scientific Consulting, S.L.
First posted: 2021-10-11
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for evaluation of PAD of the limbs when performed with duplex by a vascular specialist

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex
timeFrame: 1 day
Secondary outcomes:
measure: Determination of Presence or Absence of Significant PAD With BVE and ABPI
timeFrame: 1 day
measure: Number and Risk-classification of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 1 day
Other outcomes:
measure: Time Spent for Arterial Duplex, BVE and ABPI Vascular Assessment
timeFrame: 1 day
measure: Determination of Presence or Absence of Significant PAD With BVE by Vascular and Non-vascular Experts
timeFrame: 1 day
measure: BVE Non-diagnostic Rate
timeFrame: 1 day
Locations:
city: Brunete
country: Spain
facility: Hospital Los Madroños
state: Madrid
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Valencia
country: Spain
facility: Hospital Doctor Peset
Study officials:
affiliation: Clínica Universidad de Navarra
name: José Ignacio Leal Lorenzo
role: PRINCIPAL_INVESTIGATOR
References: