FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb… (NCT04120610) | Clinical Trial Compass
TerminatedNot Applicable
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia
Stopped: Sponsor decision to terminate study prior to reaching full sample size.
United States195 participantsStarted 2019-12-09
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cond…
What they're measuring
1
Sensitivity and Specificity of FlowMet-R for Diagnosis of PAD and CLI
Timeframe: Initial, three month, and six month time points.