Clinical trial NCT04120610: FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia
Official title: FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease (PAD) and Critical Limb Ischemia (CLI)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peripheral Artery Disease
Keywords: Peripheral Artery Disease
Claudication
Critical Limb Ischemia
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2019-10-09
Enrollment: 195
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The PAD cohort population is persons who have known or suspected peripheral artery disease, and are being seen at a vascular clinic for evaluation.

The Healthy cohort population is adult persons over 40 without history of PAD and who are not currently suspected of suffering from PAD.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and Specificity of FlowMet-R for Diagnosis of PAD and CLI
timeFrame: Initial, three month, and six month time points.
Secondary outcomes:
measure: Sensitivity and Specificity of FlowMet-R for Prognosis of Requiring a Peripheral Vascular Intervention
timeFrame: Within three and six months following initial visit
measure: Sensitivity, Specificity and Area Under the Curve (AUC) of FlowMet-R in Diagnosing Significant Stenosis
timeFrame: Initial visit
measure: Stenosis Percentage
timeFrame: Initial visit
measure: Changes in Ankle Brachial Index (ABI)
timeFrame: Within three and six months following initial visit.
measure: Changes in Toe Brachial Index (TBI)
timeFrame: Within three and six months following initial visit.
measure: Changes in Rutherford Classification
timeFrame: Within three and six months following initial visit.
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Chesterfield
country: United States
facility: Mercy Research
state: Missouri
city: New York
country: United States
facility: The Mt. Sinai Hospital
state: New York
city: Columbus
country: United States
facility: Ohio Health
state: Ohio
city: Austin
country: United States
facility: Ascension Seton
state: Texas
Study officials:
References: