NeuroThera® Effectiveness and Safety Trial - 2 (NEST-2) A Double Blind, Randomized, Controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Effectiveness of the Treatment of Acute Ischemic Stroke With the NeuroThera® Laser System Within 24 Hours From Stroke Onset
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 109
- 主要终点
- Disability scale (mRS)score at 90 days; safety of the treatment procedure
研究概览
简要总结
The purpose of this pivotal study is to demonstrate safety and effectiveness of the NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset.
详细描述
This study is a prospective, double blind, randomized, sham controlled, parallel group, multi-center study that will include enrollment of up to 660 Subjects. Subjects will be followed for 90 days post stroke onset. The primary effectiveness endpoint for this study will be the binary endpoint that defines success as a modified Rankin Scale (mRS) score of 0-2 and failure as an mRS score of 3-6 at 90 days or the last rating. The secondary effectiveness endpoint for this study will be the change in NIHSS score from baseline to 90 days or the last rating, analyzed across the full range of scores on the NIHSS. Tertiary effectiveness endpoints include: The 90-day binary endpoint, denoted as the 90-day bNIH score, based on the NIHSS score that defines a successful result as either (i) an improvement of 9 or more points on the NIHSS or (ii) a final NIHSS score of 0 or 1; the score on the mRS at 90 days or the last rating analyzed across the range of scores from 0 to 6 on the mRS scale, SIS-16 at 90 days; mortality at 30, 60 and 90 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Acute Ischemic Stroke within 24 hours
- •Clinical diagnosis of Acute Ischemic Stroke after exclusion of hemorrhage by a CT scan or susceptibility weighted MRI sequences
- •NIHSS ≥7 - ≤22
排除标准
- •>24hours from symptom onset to time of treatment
- •Evidence of intracranial, subdural, or subarachnoid hemorrhage
- •Clinical presentation of intracranial hemorrhage
- •Pre stroke ≥3 mRS
- •The presence of a brainstem or cerebellar stroke
- •Transient Ischemic Attack (TIA)
- •Seizure at stroke onset
- •Blood glucose >400 or <60
- •Sustained systolic BP >220mmHG < 80mmHG or diastolic >140mmHG <50mmHG
- •Septic embolus
- •CNS tumor (except asymptomatic meningioma)
- •Dermatologic condition of the scalp (e.g. Psoriasis)
- •Thrombolytic therapy
- •Head implant (e.g. Clipped aneurysm, Hakim valve)
结局指标
主要结局
Disability scale (mRS)score at 90 days; safety of the treatment procedure
时间窗: at baseline, day 5, 30, 60 and 90 post treatment
次要结局
- Functional neurological scale(NIHSS)over time(at baseline, Day 5, 30, 60 and 90)