PER-073-10已完成未知
EUROTHERA® EFFICACY AND SAFETY TRIAL - 3 (NEST-3) A DOUBLE-BLIND, RANDOMIZED, SHAM-CONTROLLED, PARALLEL GROUP, MULTICENTER, PIVOTAL STUDY TO ASSESS THE SAFETY AND EFFICACY OF TRANSCRANIAL LASER THERAPY WITH THE NEUROTHERA® LASER SYSTEM FOR THE TREATMENT OF ACUTE ISCHEMIC STROKE WITHIN 24 HOURS OF STROKE ONSET
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40 至 80（—）
入选标准
- •Clinical diagnosis of acute ischemic stroke
- •Subject is not a candidate for treatment with neurothrombectomy
- •Initiation of the TLT procedure begins between 4.5 and 24 hours
- •Baseline NIHSS score range: 7-17
- •Full functional independence just prior to the present stroke episode
- •Negative pregnancy test in females of childbearing potential
- •Subject Informed Consent obtained prior to enrollment into this study
排除标准
- •Evidence of an intracranial, subdural, or subarachnoid hemorrhage
- •Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes
- •Seizure at stroke onset or within the 7 days prior to stroke onset
- •Sustained blood glucose >300 or <60 mg/dl
- •Sustained hypertension (SBP >220 mmHg or DBP >140 mmHg)
- •Sustained hypotension (SBP <80 mmHg or DBP <50 mmHg)
- •A presumed and/or confirmed septic embolus
- •History of CNS vascular disease (e.g. aneurysm, AVM) or history of CNS disease or damage (e.g. neoplasm or dementia) which may influence the subject´s outcome assessment.
- •Head implant of any kind
- •Significant skin condition of the scalp (eg. psoriasis)
- •Use of any intravenous or intra-arterial thrombolytic medication
- •Use of any diagnostic or therapeutic interventional neurovascular procedure
- •Female who is pregnant or lactating or who is of childbearing potential and not using a medically acceptable method of birth control.
研究者
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