Status:
TERMINATED
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia
Lead Sponsor:
Medtronic Endovascular
Collaborating Sponsors:
ICON plc
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
40+ years
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 21 2022
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT04120610
Start Date
December 9 2019
End Date
November 21 2022
Last Update
April 11 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
The Iowa Clinic
Des Moines, Iowa, United States, 50266
2
Mercy Research
Chesterfield, Missouri, United States, 63017
3
The Mt. Sinai Hospital
New York, New York, United States, 10029
4
Ohio Health
Columbus, Ohio, United States, 43214