Early Feasibility Clinical Study of the Nervive VitalFlow Stimulation System for Treatment of Acute Ischemic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Feasibility of device use in the Clinical Environment as assessed by User Survey
研究概览
简要总结
This Early Feasibility Study (EFS) is a multi-center, open-label single-arm study in 10 acute ischemic stroke (AIS) patients treated with VitalFlow-IS stimulation within 6 hours of symptom onset. The purpose of the EFS is to evaluate initial clinical safety and device functionality in the clinical workflow setting for treatment of acute ischemic stroke patients that will inform design modifications and/or user interface in preparation for next steps consisting of (1) a full safety/feasibility clinical study and (2) randomized controlled pivotal trial with a surrogate endpoint (expedited Premarket Approval (PMA) pathway).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Time last known normal within 4.5 hours of presentation for enrollment
- •Allows 1.5 hours for pre-stimulation study procedures to maintain a 6-hour therapeutic window
- •IV rtPA and Endovascular Treatment (EVT) permissible if not inappropriately delayed by study procedures
- •Age 18-85 years
- •Diagnosis of ischemic stroke in the anterior circulation
- •NIHSS at baseline 4-20
- •Creatinine < 1.7 mg/dL
- •Signed informed consent by patient/Legally Authorized Representative (LAR)
排除标准
- •Pre-stroke disability Modified Rankin Score (mRS) between 2-6
- •Inability to communicate sufficiently to participate in study procedures
- •Neuroimaging with intracranial hemorrhage, severe brain edema, or ASPECTS <5
- •Known or newly-discovered aneurysm or arteriovenous malformation (AVM)
- •Intracranial mass lesion, infection, or other reason to suspect increased intracranial pressure
- •Metallic foreign bodies or implanted devices in the head or neck, including tattoos
- •Cardiac, vagal nerve, or intracranial neural stimulation device
- •Cochlear implant or implanted hearing aid
- •Potential for delay in intravenous rtPA or endovascular therapy due to study procedures
- •Intravenous (IV) rtPA: Stimulation might be delivered during the rtPA infusion period
- •EVT: Stimulation might be performed while EVT team is mobilized
- •Seizure concurrent to stroke, or history of seizures, epilepsy, or recurrent syncopal events.
- •History of neuropathy (including facial nerve injury), carotid surgery, or vagotomy.
结局指标
主要结局
Feasibility of device use in the Clinical Environment as assessed by User Survey
时间窗: 1-7 days post-procedure
To demonstrate feasibility, device must have been able to be setup, deployed, and administer treatment without significant difficulty for each study subject, as recorded by the Investigator on the User Survey.
Rate of device-related adverse events
时间窗: 90 days post-procedure
Rate of device-related adverse events
次要结局
- Exploratory - Rate of change in penumbra volume as measured by Computed Tomography Perfusion(2-4 hours post-procedure)
- Exploratory - Difference in baseline core volume on CTP compared to 24 hour MRI final infarct volume(24 hours post-procedure)
- Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - 24 hours(24 hours post-procedure)
- Exploratory - Patient Outcome as determined by Modified Rankin Scale (mRS)(90 days post-procedure)
- Exploratory - Rate of change in collateral blood flow as measured by Computed Tomography Perfusion(2-4 hours post-procedure)
- Exploratory - Rate of change in occlusion status as measured by Computed Tomography Perfusion(2-4 hours post-procedure)
- Exploratory - Patient Outcome as determined by National Institute of Health Stroke Scale (NIHSS)(90 days post-procedure)
- Exploratory - Rate of change in core volume as measured by Computed Tomography Perfusion(2-4 hours post-procedure)
- Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - short-term(Pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure)
- Exploratory - Final change in infarct growth - CTP (CBF<30%) at pre-stimulation vs MRI-DWI lesion at 24 hours(24 hours post-procedure)