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

Medtronic

Status: Terminated

Conditions: Peripheral Artery Disease

Treatments: Diagnostic Test: ABI; Diagnostic Test: FlowMet-R; Diagnostic Test: TBI

Study type: Observational

Funder types: Industry

Identifiers

NCT04120610

30081919

Details and patient eligibility

About

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.

Full 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.

Enrollment: 195 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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

Trial design

195 participants in 2 patient groups

Healthy

Description:

Healthy cohort is an age-matched population (over 40 years old) without history of PAD or suspected PAD. Healthy cohort will receive FlowMet-R measurement, Ankle Brachial Index (ABI), and Toe Brachial Index (TBI) measurements.

Treatment:

Diagnostic Test: TBI

Diagnostic Test: FlowMet-R

Diagnostic Test: ABI

Peripheral Artery Disease

Description:

PAD cohort is all-comers to the vascular lab that are scheduled to undergo assessment for Peripheral Artery Disease (PAD) or have a planned endovascular or surgical intervention to address PAD and will receive FlowMet-R measurement in addition to their routine standard of care.

Treatment:

Diagnostic Test: TBI

Diagnostic Test: FlowMet-R

Diagnostic Test: ABI