N/A
Completed N=187
Clinical Evaluation of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease
Source: ClinicalTrials.gov NCT05073510 ↗Enrolled (actual)
187
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex — 62; 14; 212; 43 Limbs
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex |
62; 14; 212; 43 | — |
| SECONDARY Determination of Presence or Absence of Significant PAD With BVE and ABPI |
62; 11; 202; 51 | — |
| SECONDARY Number and Risk-classification of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT05073510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.