Implant for Augmentation of Cerebral Blood Flow Trial-1. A Pilot Study Evaluating the Safety and Effectiveness of the Ischemic Stroke System for Treatment of Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Treatment successful completion
研究概览
简要总结
The primary objective of this pilot study is the assessment of the safety of the ISS500 System in patients who have experienced an acute ischemic stroke within the anterior circulation.
The secondary objectives of this study are to examine the effectiveness of the ISS500 System implantation in the treatment of acute ischemic stroke.
详细描述
The study is an open label study in which a comparative group of patients will be prospectively selected from a resource of clinical trial data, the Virtual International Stroke Trials Archive (VISTA), on the basis of similar eligibility criteria and match for principal prognostic variables available at trial entry. Data from patients will be transferred to VISTA in a real time or at most, weekly basis and comparative group patients will be prospectively matched throughout the recruitment period. The VISTA investigators will be blinded to treatment group when receiving data from BrainsGate. The VISTA investigators will match each recruited BrainsGate patient with 3 patients from the VISTA archive. The matching criteria will include age ± 4 years; baseline NIH score matched exactly, and side of infarct.
In addition, to the end of treatment visit, in which implanted patients will undergo a device removal procedure, two follow-up visits will be performed. The visits should be performed at 30±5, and at 90±5 post enrollment. Aggregate trial duration will be ~100 days per patient, and the overall study duration will be up to 18 months.
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
- •Age: ≥ 18 years and ≤ 85 of both genders
- •Patients with symptoms and signs of an acute ischemic hemispheric stroke within the anterior circulation.
- •NIHSS ≥ 7 and ≤ 20
- •Treatment can be initiated within the first 24 hours following stroke onset or since last seen normal.
- •Signed informed consent has been obtained from the patient him/herself or his/her legally authorized representative
排除标准
- •Time interval since onset of symptoms undetermined
- •Treatment with ISS500 System can't start within the first 24 hours post stroke onset
- •Any other imaging diagnosis including tumor, abscess, primary intracranial hemorrhage (ICH) or secondary hemorrhage (PH1-PH2) (H1 and H2 are allowed); or symptoms suspicious for sub-arachnoid hemorrhage, etc
- •Clinical syndrome of an acute stroke due to lacunar infarct (pure motor hemiparesis, ataxic hemiparesis, sensorimotor stroke), unless brain imaging demonstrates a relevant lesion > 1.5 cm in size
- •Not a stroke in the anterior circulation
- •Minor stroke with non-disabling deficit or rapidly improving neurological symptoms with a high probably to Transient Ischemic Attack (TIA)
- •Eligible to or treated with IV or IA t-PA or mechanical thrombolysis
- •Baseline NIHSS >20 or < 7
- •Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score greater than or equal to 2)
- •History of stroke in previous 6 months
- •Pre-existing disability; Modified Rankin Score > 2 upon screening
- •Patients under oral anticoagulants or having received heparin within 48 hours, and / or with elevated activated partial thromboplastin time (aPTT) (or INR)
- •High clinical suspicion of septic embolus
- •Severe cardiac disease: evidence of congestive heart failure or has history of endstage cardiovascular disease (e.g. CHF NYHA Class III or IV or unstable angina)
- •Uncontrolled hypertension upon enrollment (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
- •Orthodontics or non-Hygienic condition/ problems that prevent procedures within the mouth
- •MRI2 contraindications, such as but not limited to:
- •Central nervous system aneurysm clips
- •Implanted cardiac pacemaker or defibrillator;
- •Cochlear implant
- •Ocular foreign body (e.g. metal shavings)
- •Insulin pump
- •Metal shrapnel or bullet
- •Any implanted device that is incompatible with MRI.
- •Patients with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.)
- •Life expectancy < 1 year from other causes
- •Currently participating in any other clinical trial
- •Patients unable or unwilling to follow protocol requirements
- •Massive stroke, defined as acute parenchymal hypodense lesion or effacement of cerebral sulci in over a 2/3 of the MCA territory per CT (or equivalent per T2/Flair/DWI MRI)
研究组 & 干预措施
Active Stimulation
The Implant will be implanted using a minimal invasive approach. Following implantation, a CT localization imaging should be performed as soon as possible following the implant procedure. ISS (Ischemic Stroke System) stimulation of the SPG (Sphenopalatine Ganglionduring) for 5 consecutive days.
干预措施: ISS Active Stimulation (Device)
结局指标
主要结局
Treatment successful completion
时间窗: 5 Days
The need to stop the treatment sessions completely or alternately.
Adverse Events profile at 90 Day compared to VISTA trials data
时间窗: 90 Days
Adverse Events profile at 90 days post implantation will be compared to the data retrieved form the VISTA trials.
次要结局
- The distribution of modified Rankin scale scores at 90 days(90 Days)
- NIHSS scores at 90 days(90 Days)
- Proportion of patients achieving a Barthel index at 90 days(90 Days)