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NCT04120610 · ClinicalTrials.gov registry record
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia
A clinical trial, sponsored by Medtronic Endovascular.
- Terminated
- Registry status
- 195
- Enrollment target
NCT04120610: Clinical Trial study, sponsored by Medtronic Endovascular.
NCT04120610 is a clinical trial that was terminated before completion, run by Medtronic Endovascular. The registered enrollment target is 195 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04120610 was terminated before completion, sponsored by Medtronic Endovascular.
- TERMINATED
- Registry status
- 195 participants
- Enrollment target
Study 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.
Primary Outcome
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 fo
Interventions
- DIAGNOSTIC_TEST FlowMet-R
- DIAGNOSTIC_TEST ABI
- DIAGNOSTIC_TEST TBI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2019-12-09 |
| Est. Completion | 2022-11-21 |
Why NCT04120610 stopped before completion
NCT04120610 is an observational study that tracks outcomes without assigning an intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which FlowMet-R is the first listed.
NCT04120610 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04120610 about?
NCT04120610 is a clinical study titled "FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia". 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.
What is the current status of trial NCT04120610?
This trial is currently terminated. The enrollment target is 195 participants. The study started on 2019-12-09. Estimated completion is 2022-11-21.
What interventions are being tested in trial NCT04120610?
The interventions under investigation include: FlowMet-R (DIAGNOSTIC_TEST), ABI (DIAGNOSTIC_TEST), TBI (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04120610?
This trial is sponsored by Medtronic Endovascular, which has 25 total clinical trials registered on ClinicalTrials.gov.
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