FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease (PAD) and Critical Limb Ischemia (CLI)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 195
- 试验地点
- 5
- 主要终点
- Sensitivity and Specificity of FlowMet-R for Diagnosis of PAD and CLI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Sensitivity and Specificity of FlowMet-R for Diagnosis of PAD and CLI
时间窗: 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).
次要结局
- 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.)