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 Details — Status: Terminated

Administrative data

• NCT number: NCT04120610
• Other study ID #: 30081919
• Status: Terminated
• Start date: December 9, 2019
• Est. completion date: November 21, 2022

Study information

• Verified date: January 2023
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 196
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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 willing and 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

Related Conditions & MeSH terms

• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Diagnostic Test:
• FlowMet-R
FlowMet-R is a noninvasive blood flow measurement.
• ABI
Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm.
• TBI
Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm.

Locations

Country	Name	City	State
United States	Ascension Seton	Austin	Texas
United States	Mercy Research	Chesterfield	Missouri
United States	Ohio Health	Columbus	Ohio
United States	The Iowa Clinic	Des Moines	Iowa
United States	The Mt. Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of FlowMet-R for diagnosis of PAD and CLI	Receiver operating characteristic (ROC) curves for the diagnosis of PAD and, independently, CLI, will be generated using FlowMet-R measurement data. ROC curves will be used to compute the peak sensitivity, peak specificity, and area under the curve (AUC).	Initial, three month, and six month time points.
Secondary	Sensitivity and specificity of FlowMet-R for prognosis of requiring a peripheral vascular intervention	ROC curves for predicting a patient will undergo intervention following their initial visit will be generated using FlowMet-R measurement data. ROC curves will be used to compute the peak sensitivity, peak specificity, and area under the curve (AUC).	Within three and six months following initial visit
Secondary	Sensitivity and specificity of FlowMet-R in diagnosing significant stenosis	ROC curves for predicting a patient has significant stenosis, defined by greater than 50%, in at least one peripheral artery will be generated using FlowMet-R measurement data. ROC curves will be used to compute the peak sensitivity, peak specificity, and area under the curve (AUC).	Initial visit
Secondary	Correlation between FlowMet-R measurements and stenosis percentage	A correlation test will be performed between FlowMet-R and stenosis percentage	Initial visit
Secondary	Correlation between changes in FlowMet-R measurement and changes in standard diagnostics	A correlation test will be performed between changes in FlowMet-R measurement and changes in standard diagnostics between visits.	Within three and six months following initial visit.