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FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia

Peripheral Artery Disease Clinical Trial

Official title:
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease (PAD) and Critical Limb Ischemia (CLI)

Clinical Trial Summary

Non-randomized, multi-center, longitudinal study of healthy subjects and subjects with PAD who are scheduled for ABI, TBI, and either Duplex Ultrasound or Angiographic assessments in a vascular clinic.

Clinical Trial Description

Patients scheduled for peripheral vascular examination and healthy controls will be measured with the FlowMet-R, a noninvasive blood flow monitor, and compared to gold standard diagnostics - ABI, TBI, and Doppler Ultrasound. Sensitivity and specificity of the FlowMet-R device output in diagnosing PAD and CLI will be assessed on initial visit, 3-month followup, and 6-month followup. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04120610
Study type Observational [Patient Registry]
Source Medtronic Endovascular
Contact
Status Terminated
Phase
Start date December 9, 2019
Completion date November 21, 2022
View Details
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