FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease (PAD) and Critical Limb Ischemia (CLI)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- Medtronic Endovascular
- Enrollment
- 195
- Locations
- 5
- Primary Endpoint
- Sensitivity and Specificity of FlowMet-R for Diagnosis of PAD and CLI
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
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.
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.
Outcomes
Primary Outcomes
Sensitivity and Specificity of FlowMet-R for Diagnosis of PAD and CLI
Time Frame: Initial, three month, and six month time points.
Primary objective is to determine the efficacy of FlowMet-R measurements in diagnosing PAD \& CLI. All patients were combined from healthy \& PAD groups to form one cohort, ABI and TBI were then used to assign patients in PAD (1), PAD (2) \& CLI. FlowMet-R data (comprised of blood flow measurements and/or feature analysis of the blood flow waveform) were used to create a predictive model of PAD severity. This model was used to generate diagnostic receiver operating characteristic (ROC) curves for PAD and, independently, CLI, at three time points. ROC curves were used to compute the peak sensitivity, peak specificity, and area under the curve (AUC) at the initial, 3-month and 6-month time points. Sensitivity, specificity and AUC are unitless. Sensitivity is the percentage of true positives \& specificity is the percentage of true negatives at the location on the ROC curve where it was closest to the upper left of the unit square from an ROC curve (peak).
Secondary Outcomes
- Sensitivity and Specificity of FlowMet-R for Prognosis of Requiring a Peripheral Vascular Intervention(Within three and six months following initial visit)
- Sensitivity, Specificity and Area Under the Curve (AUC) of FlowMet-R in Diagnosing Significant Stenosis(Initial visit)
- Stenosis Percentage(Initial visit)
- Changes in Ankle Brachial Index (ABI)(Within three and six months following initial visit.)
- Changes in Toe Brachial Index (TBI)(Within three and six months following initial visit.)
- Changes in Rutherford Classification(Within three and six months following initial visit.)