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
- 终止
- 发起方
- 入组人数
- 327
- 试验地点
- 9
- 主要终点
- Number of participants with neurological deterioration
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
This study was first registered as NCT00826059 on January 19, 2009 under the name ImpACT-24.
Background:
Recruitment to ImpACT-24 was halted, the protocol was amended and then the study was resumed. Later, it was decided to define the first part (before the halt) as a separate study - ImpACT-24A, and identify the continuation of the study as ImpACT-24B. ImpACT-24B continues to be registered as NCT00826059, and ImpACT-24A is registered in this new record.
Detailed Description:
A multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard of Care, parallel arm study with ongoing DSMB review of accumulated safety data.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 18 years and ≤ 85 of both genders.
- •Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
- •Baseline NIHSS ≥ 7 and ≤ 18
- •Ability to initiate treatment within 8- 24 hours from stroke onset.
排除标准
- •Intracranial hemorrhage or hemorrhagic transformation
- •Massive stroke
- •Acute ischemic stroke in the posterior circulation
- •Minor stroke
- •Treated with IV-tPA ,IA-tPA 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
- •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.
研究组 & 干预措施
Active Stimulation
Device: The Ischemic Stroke System SPG stimulation and standard of care
干预措施: Active Stimulation (Device)
Sham Stimulation
Device: Sham control Sham stimulation and standard of care
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Number of participants with neurological deterioration
时间窗: 10 days
Comparison between the active and sham stimulation groups of the rate of neurological deterioration, defined as an increase of 4 or more points on the NIHSS related to any neurological event within the first 10 days after stroke onset
Mortality rate
时间窗: 90 ±7 days
Comparison of mortality rates between the active and sham stimulation groups
Number of participants with Serious Adverse Events
时间窗: 90 ±7 days
Comparison between the active and sham stimulation groups of all serious adverse events (SAEs)
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
时间窗: 90 ±7 days
Final global disability level on the modified Rankin scale (mRS) at 3 months better than expectation (sliding dichotomy analysis) ) assessed in the modified intention to treat (mITT) population defined as all randomized subjects receiving at least the minimal exposure of 1 treatment (ISS Stimulation or Sham Control) session out of the 5 planned sessions. mRS Scale: * 0 - No symptoms. * 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. * 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. * 3 - Moderate disability. Requires some help, but able to walk unassisted. * 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. * 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. * 6 - Dead.
Number of participants with implantation complications
时间窗: 90 ±7 days
The rate of implantation complications as classified by the investigator
Number of participants with stimulation-related adverse events
时间窗: 90 ±7 days
Comparison between the active and sham stimulation groups of stimulation-related adverse events as classified by the investigator
次要结局
- Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline(90 ±7 days)
- Binary NIHSS at Day 90(90 ±7 days)
- Stroke-related quality of life at 3 months: Stroke Impact Scale-16(90 ±7 days)