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

Stopped early

Conditions studied: Peripheral Artery Disease

In brief

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.

Key facts

Study ID

NCT04120610

Run by

Medtronic Endovascular

People needed

195

Starts

2019-12-09

Expected to finish

2022-11-21

Last updated by the study team

2025-04-11

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• PAD Positive Cohort
• Subject meets PAD positive criteria
• Subject is willing and able to provide informed consent
• Subject is willing and able to comply with study procedures
• Subject is able to understand the study procedures
• Subject is scheduled for vascular examination that includes noninvasive assessments as standard of care: ABI, TBI, and either a Duplex Ultrasound or Angiogram
• Healthy Cohort
• Subject is willing and able to provide informed consent.
• Subject is willing and able to comply with the study procedures.
• Subject is able to understand the study procedures.
• Subject has no history of positive PAD diagnosis, and is not currently suspected of having PAD.

You may not qualify if…

• PAD Positive Cohort
• Subject is under 40 or unable to consent.
• Subject has any medical condition, which, in the judgment of the Investigator and/or designee, makes the subject a poor candidate for the investigational study.
• Subject is excluded from analysis if no stenosis is found during Doppler but Tibial disease is suspected and Tibial ultrasound is not able to be performed.
• Subject does not have a suitable finger to attach the FlowMet-R probe.
• Subject does not have a suitable 1st or 2nd digit to attach FlowMet-R probe on the limb of interest.
• Subject has undergone revascularization within the last 90 days
• Subject cannot lay safely in a supine position.
• Healthy Cohort
• Subject is under 40 or unable to consent.
• Subject has any medical condition, which, in the judgment of the Investigator and/or designee, makes the subject a poor candidate for the investigational study.
• One or more limbs has a prior or current diagnosis of PAD, or is reasonably suspected of having a diagnosis of PAD.
• Subject does not have a suitable finger to attach the FlowMet-R probe.
• Subject does not have a suitable 1st or 2nd digit to attach FlowMet-R probe.
• Subject has undergone revascularization within the last 90 days

Where it is running

• The Iowa Clinic — Des Moines, Iowa, United States
• Mercy Research — Chesterfield, Missouri, United States
• The Mt. Sinai Hospital — New York, New York, United States
• Ohio Health — Columbus, Ohio, United States
• Ascension Seton — Austin, Texas, United States

Full record on ClinicalTrials.gov

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