CLINICAL TRIAL: TREATMENT OF ACUTE ISCHEMIC STROKE WITH THE NEUROTHERA? LASER SY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项关键研究的目的是证明NeuroThera激光系统(以下简称NTS)在治疗被诊断为急性缺血性中风的受试者中的安全性和有效性。NTS治疗的开始必须在卒中发病24小时内对每个受试者都是可行的。NeuroThera激光系统是一种研究设备，为被诊断为急性缺血性中风的患者提供非侵入性经颅激光治疗。这项研究是一项前瞻性、双盲、随机、假对照、平行分组、多中心研究，将包括多达50个研究地点的660名受试者(美利坚合众国和国际中心加在一起)。研究人群将随机分为两组：假对照组(SCG)和实验治疗组(ETG)。一般来说，有资格参加研究的患者将被诊断为急性缺血性中风，并在某个时间提交给卫生保健机构，以便在中风发作后24小时内可以进行NTS治疗。此外，受试者在筛查之日的年龄需要在40岁至90岁之间。被允许进入研究的受试者包括那些符合所有纳入标准且没有任何排除标准的受试者。预计受试者将参加为期90天的研究。这项研究的主要有效性终点将是二元终点，它将成功定义为修改后的Rankin量表(MRS)评分0-2，将失败定义为90天或最后一次评级时MRS评分3-6(以下称为90天结果)。安全终点包括通过90天随访的与研究装置相关的累积无不良事件存活率、通过90天随访的与程序相关的累积无不良事件存活率、通过NTS治疗后90天随访的与研究装置相关的累积意外事件的数量和百分比以及通过90天的不良事件将红外线能量传递到预定部位时NTS的安全性。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 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. The NeuroThera¿ Laser System is an investigational device that provides non-invasive transcranial laser treatment to subjects diagnosed with acute ischemic stroke. This study is a prospective, double blind, randomized, sham controlled, parallel group, multi-center study that will include enrollment of up to 660 subjects at up to 50 investigational sites (United States of America and international centers combined). The study population will be randomized into two arms: Sham Control Group (SCG) and Experimental Treatment Group (ETG). In general, patients eligible for study participation will be diagnosed with acute ischemic stroke and present to the Health Care Facility at a time such that NTS treatment will be feasible within 24 hours of the time of stroke onset. In addition, subjects will need to be between 40 and 90 years of age on the date of screening. Subjects who will be permitted into the study include those who will meet all the inclusion criteria and will have none of the exclusion criteria. It is expected that the subjects will participate in the study for 90 days. 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, (hereafter referred to as the 90-day result). The safety endpoints include the cumulative investigational device-related adverse event-free survival through 90 days of follow-up, the cumulative procedure-related adverse event-free survival through 90 days of follow-up, the number and percent of cumulative unanticipated investigational device-related, and cumulative unanticipated procedure-related adverse events through 90 days of follow-up after treatment with the NTS, and the safety of NTS in the delivery of infrared energy to the intended site based on adverse events though 90 days.