A Prospective, Multicenter, Nonrandomized, Open-label, Single-arm Study of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- BlueDop Medical LTD
- Enrollment
- 187
- Locations
- 4
- Primary Endpoint
- Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex
Time Frame: 1 day
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)
Secondary Outcomes
- 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)