NCT04120610

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 195 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FlowMet-R	FlowMet-R is a noninvasive blood flow measurement.
DIAGNOSTIC_TEST	ABI	Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm.
DIAGNOSTIC_TEST	TBI	Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm.

Timeline

• Start date: 2019-12-09
• Primary completion: 2022-11-21
• Completion: 2022-11-21
• First posted: 2019-10-09
• Last updated: 2025-04-11
• Results posted: 2025-04-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study