PER-016-07已完成未知
euroThera® 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
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
- 0 至 0（—）
入选标准
- •1. The Subject is at least 40 years old at the time of detection, but less than 91 years old.
- •2. The Subject suffers from acute ischemic stroke and presents to the community hospital to receive treatment with NTS within the first 24 hours of the onset of his symptoms.
- •3. Clinical diagnosis of ischemic stroke as a cause of measurable neurological deficit.
- •4. Total score on the NIHSS scale of ≥ 7 and ≤ 22 on the NIH ACV Scale evaluated at the time of admission to the Community Hospital.
- •5. Negative pregnancy test in women with potential risk of pregnancy.
- •6. The subject and / or their legal representative give their informed consent before enrolling in the study.
- •7. The Subject wishes to participate in this study for at least 3 months after the start of the ACV.
- •8. It is the opinion of the Principal Investigator that the Subject is an appropriate candidate for the management of the LCA using an NTS.
排除标准
- •1. The Subject has been presented to the Community hospital more than 24 hours after the start of the ACV.
- •2. Evidence of intracranial, subdural or subarachnoid hemorrhage on CT or MRI.
- •3. Clinical picture of the subject suggestive of primary intracranial hemorrhage.
- •4. Presence of cerebral infarction of the brainstem or cerebellum.
- •5. Rapid deterioration of neurological status.
- •6. Subject with presence of value ≥ 3 on the scale of mRS prior to the ACV.
- •7. The subject had seizures at the beginning of the stroke or seizures were observed in the 7 days prior to enrollment in the study.
- •8. Serum glucose greater than 400 mg / dl or less than 60 mg / dl.
- •9. Sustained hypertension or the need for aggressive treatment for the reduction of blood pressure during the initial period.
- •10. Sustained hypotension.
- •11. Presumed and / or confirmed septic plunger.
- •12. CNS tumors.
- •13. The subject has an alteration of the skin at the chosen site for the application of infrared energy.
- •14. The subject is a candidate for the administration of intravenous or intraarterial thrombolytic medication for the treatment of acute ischemic stroke and will be given thrombolytic therapy.
- •15. The subject has previously participated in another study of experimental drugs or devices in the previous 4 weeks.
- •16. Subject is a woman who is pregnant, breastfeeding or has the potential to become pregnant, unless it is surgically sterile, or she and her partner use a medically acceptable method of contraception.
- •17. Implant prosthesis in the head.
- •18. Use of light activated drugs within 14 days prior to enrollment in the study.
- •19. Coexistence of severe terminal systemic disease.
- •20. It has been determined by the Investigator that the subject is medically not suitable for participation in the study.
研究者
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