At a glance
ClinicalIndex Comparison RecordN/ACompleted· 187 enrolled
Drug / intervention
BVEdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multicenter, Nonrandomized, Open-label, Single-arm Study of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease
In Brief
An observational study evaluating BVE for Peripheral Arterial Disease. Completed, enrolled 187 participants across 4 sites.
Detailed 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).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease
CountriesSpain
CollaboratorsAKRN Scientific Consulting, S.L.
Timeline
N/ACompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartOct 2021
Primary CompletionSep 2023
TodayJul 2026
First PostedOct 11, 2021
Enrollment StartOct 11, 2021
Primary CompletionSep 11, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.7 years ago
Interventions
BVEdevice
Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)