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

NCT04120610 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 195

Last updated 2025-04-11

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Medtronic Endovascular

    lead INDUSTRY

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-09
Primary Completion
2022-11-21
Completion
2022-11-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04120610 on ClinicalTrials.gov