- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04120610
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia
January 9, 2023 updated by: Medtronic Endovascular
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease (PAD) and Critical Limb Ischemia (CLI)
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
196
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Iowa
-
Des Moines, Iowa, United States, 50266
- The Iowa Clinic
-
-
Missouri
-
Chesterfield, Missouri, United States, 63017
- Mercy Research
-
-
New York
-
New York, New York, United States, 10029
- The Mt. Sinai Hospital
-
-
Ohio
-
Columbus, Ohio, United States, 43214
- Ohio Health
-
-
Texas
-
Austin, Texas, United States, 78705
- Ascension Seton
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy
Healthy cohort is an age-matched population (over 40 years old) without history of PAD or suspected PAD.
Healthy cohort will receive FlowMet-R measurement, Ankle Brachial Index (ABI), and Toe Brachial Index (TBI) measurements.
|
FlowMet-R is a noninvasive blood flow measurement.
Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm.
Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm.
|
PAD
PAD cohort is all-comers to the vascular lab that are scheduled to undergo assessment for Peripheral Artery Disease (PAD) or have a planned endovascular or surgical intervention to address PAD.
PAD cohort patients will receive FlowMet-R measurement in addition to their routine standard of care.
|
FlowMet-R is a noninvasive blood flow measurement.
Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm.
Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of FlowMet-R for diagnosis of PAD and CLI
Time Frame: Initial, three month, and six month time points.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of FlowMet-R for prognosis of requiring a peripheral vascular intervention
Time Frame: Within three and six months following initial visit
|
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
|
Sensitivity and specificity of FlowMet-R in diagnosing significant stenosis
Time Frame: Initial visit
|
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
|
Correlation between FlowMet-R measurements and stenosis percentage
Time Frame: Initial visit
|
A correlation test will be performed between FlowMet-R and stenosis percentage
|
Initial visit
|
Correlation between changes in FlowMet-R measurement and changes in standard diagnostics
Time Frame: Within three and six months following initial visit.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2019
Primary Completion (Actual)
November 21, 2022
Study Completion (Actual)
November 21, 2022
Study Registration Dates
First Submitted
October 7, 2019
First Submitted That Met QC Criteria
October 7, 2019
First Posted (Actual)
October 9, 2019
Study Record Updates
Last Update Posted (Estimate)
January 11, 2023
Last Update Submitted That Met QC Criteria
January 9, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30081919
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Artery Disease
-
Janssen Scientific Affairs, LLCHCA Research Institute, LLCRecruitingCoronary Artery Disease (CAD) | Peripheral Artery Disease (PAD)United States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedStructural Heart Disease | Obstructive Coronary Artery Disease | Obstructive Peripheral Artery DiseaseUnited States
-
Fangge DengRecruitingPeripheral Artery Disease (PAD)China
-
Fundacion para la Formacion e Investigacion Sanitarias...Not yet recruiting
-
Rontis Hellas SAPharmassist LtdActive, not recruitingPeripheral Artery Disease (PAD)Greece
-
Michael Lichtenberg, MDCompletedPeripheral Artery Disease (PAD)Germany
-
Helsinki University Central HospitalCompletedPeripheral Artery Occlusive Disease | Peripheral Artery Stenosis | Peripheral Artery RestenosisFinland
-
Boston Scientific CorporationCompletedAtherosclerosis | Peripheral Artery Disease | Plaque, Atherosclerotic | Artery Diseases, Peripheral | Occlusive Arterial DiseaseUnited States, Belgium, Canada, Japan, Austria, New Zealand
-
Seung-Whan Lee, M.D., Ph.D.Active, not recruitingCatheterization, Peripheral | Popliteal Artery | Angioplasty, Balloon | Femoral ArteryKorea, Republic of
-
Dartmouth-Hitchcock Medical CenterSociety for Vascular SurgeryCompletedPeripheral Artery Disease (PAD)United States
Clinical Trials on FlowMet-R
-
The Cleveland ClinicWithdrawnCritical Limb IschemiaUnited States
-
Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI); Medtronic EndovascularEnrolling by invitationCritical Limb IschemiaUnited States
-
Eunice Kennedy Shriver National Institute of Child...SuspendedCOVID-19 | Upper Respiratory Infection | Lower Respiratory InfectionUnited States
-
University of California, Los AngelesUniversity of Colorado, Denver; National Institute of Allergy and Infectious... and other collaboratorsCompletedRNA Virus Infections | Respiratory Tract Infections | Influenza, Human | Orthomyxoviridae Infections | Respiratory Tract Disease | Virus Disease | Physiological Effects of Drugs | VaccinesUnited States
-
Klinikum NürnbergUnknown
-
University of California, Los AngelesNational Institute of Allergy and Infectious Diseases (NIAID)CompletedRespiratory Tract Infections | Influenza | VaccinesUnited States
-
LifeScanCompleted
-
Daping Hospital and the Research Institute of Surgery...Not yet recruiting
-
Assistance Publique - Hôpitaux de ParisCompletedHealthy VolunteersFrance