A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Effectiveness and Safety of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects With Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,078
- 试验地点
- 80
- 主要终点
- Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
研究概览
简要总结
The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset.
详细描述
A multi-center, multinational, randomized, blinded, sham control, adjunctive to Standard of Care, parallel arm study and will include ongoing Data Safety and Monitoring Board (DSMB) review of accumulated safety data.
Screening:
Since the treatment should be initiated within 24 hours from stroke onset, the screening window is limited and all procedures should be performed within this window.Subjects with Acute Ischemic Stroke will be screened upon arrival to the hospital. Since the treatment should be initiated between 8 and 24 hours from stroke onset, the screening window is limited and all procedures should be performed as soon as possible. All screened patients will be identified by patient number and will sign the informed consent prior to any study procedure initiation.
Period 1: Day 1-5
Day 1- Eligible subjects will be randomized to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Between 40 years and 80 years for male and 85 for female subjects
- •Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
- •Imaging findings demonstrating signs of ischemia in the anterior circulation, consistent with the clinical diagnosis
- •Baseline NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
- •Ability to initiate treatment within 8- 24 hours from stroke onset
- •Signed informed consent from patient him/herself or legally authorized representative if applicable
排除标准
- •Intracranial hemorrhage or hemorrhagic transformation
- •Massive stroke
- •Acute ischemic stroke in the posterior circulation
- •Minor stroke
- •Treated with IV-tPA (intravenous tissue Plasminogen Activator) ,IA-tPA (intra-arterial tissue Plasminogen Activator) or neurothrombectomy devices for the current stroke
- •Previous stroke in the last 6 months or pre-existing disability
- •Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
- •Clinical signs and symptoms or imaging evidence of bilateral stroke.
- •Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke.
- •Known cerebral arteriovenous malformation, cerebral aneurysm.
- •Clinical suspicion of septic embolus.
- •Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)
- •Serious systemic infection.
- •Women known to be pregnant or having a positive or indeterminate pregnancy test.
- •Patients with other implanted neural stimulator/ electronic devices (pacemakers).
- •Life expectancy < 1 year from causes other than stroke.
结局指标
主要结局
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
时间窗: 90 days±7 days
The primary efficacy endpoint is improvement beyond expectations on the modified Rankin Scale at 3 months (sliding dichotomy), assessed in primary populations of: 1. modified intention to treat (mITT) 2. confirmed cortical involvement (CCI), defined as baseline NIHSS ≥ 10 and signs of cortical involvement in baseline imaging (at least one of the following ASPECT regions: M1-M6, Insular Cortex) Type I Error is controlled at an overall level of 0.05 (two-sided) using the Hochberg method.
次要结局
未报告次要终点