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

Peripheral Arterial Disease Clinical Trial

Official title:

A Prospective, Multicenter, Nonrandomized, Open-label, Single-arm Study of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073510
• Other study ID #: BVE-01
• Status: Recruiting
• Start date: October 11, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: BlueDop Medical LTD
• Contact: José Ignacio Leal Lorenzo
• Phone: +34 625 587 795
• Email: jleall[@]unav.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Los Madroños	Brunete	Madrid
Spain	Clínica Universidad de Navarra	Madrid
Spain	Hospital de Manises	Manises	Valencia
Spain	Hospital Doctor Peset	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
BlueDop Medical LTD	AKRN Scientific Consulting, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	BVE non-diagnostic rate	Number of patients and/or limbs that could not be assessed by BVE.	1 day
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)	1 day
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.	1 day
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	1 day