Interventional Management of Stroke Phase III Trial - SDCC

描述(申请人提供)：急性缺血性中风的临床实践正处于关键时刻。FDA批准的去斑点设备的使用正在迅速扩大，未来几年将有更多的设备进入临床实践。这一临床实践的重大变化自2004年以来加速，因为第一个FDA批准的设备用于 血栓清除器用于急性中风患者，并且在没有临床数据表明这些设备与标准治疗(发病三小时内静脉注射rt-PA)相比改善患者预后的情况下进行。正在进行的中风多中心介入治疗(IMS)III试验是唯一一项将标准疗法与一种方法进行比较的随机III期试验，这种方法结合了静脉注射rt-PA，然后用设备和/或la rt-PA清除血栓。这项试验的数据对于指导临床和公共卫生决策有关急性缺血性卒中血管内治疗的ROE至关重要。IMS III试验的主要目标是 与接受标准IVRT-PA治疗的患者相比，基线NIHSS评分为10分，或NIHSS评分为8-9分，有证据表明大脑中动脉、ICA或基底动脉被CTA阻塞的缺血性中风患者，与接受标准IV RT-PA治疗的患者相比，在发病后3小时内开始接受IV+IA联合治疗的患者，是否更有可能获得良好的结果，定义为随机90天后评估的改良Rankin量表评分0-2。两个治疗组还在额外的临床结果测量、成像和安全性数据方面进行了比较。此外，还对IV+IA组合方案的成本效益进行了评估。这项试验目前得到两笔NINDS合作协议赠款的支持：(1)向辛辛那提大学临床协调和血管成像中心(PI：Joseph P.Broderick，MD)提供临床领导以及项目和现场管理；(2)向南卡罗来纳医科大学统计和数据协调中心(SDCC)(PI：Yuko Y.Palesch，PhD)提供数据管理和统计专业知识。SDCC此次竞争性续签申请的目的是与试验调查人员密切合作，以最高标准的数据质量成功完成IMS III试验。

DESCRIPTION (provided by applicant): The clinical practice of acute ischemic stroke is at a critical juncture. The use of dot-removal devices approved by the FDA is rapidly expanding, and more devices are poised to enter clinical practice in next several years. This major change in clinical practice has accelerated since 2004 after the approval of the first FDA-cleared device for thrombus removal in acute stroke patients and is occurring without clinical data demonstrating that these devices improve patient outcome as compared to standard therapy (IV rt-PA within three hours of onset). The ongoing multicenter Interventional Management of Stroke (IMS) III Trial is the only randomized Phase III trial that compares the standard therapy to an approach that combines IV rt-PA followed by lA removal of thrombus by devices and/or lA rt-PA. Data from this Trial are critical to inform clinical and public health policy decisions regarding the roe of endovascular therapy for acute ischemic stroke. The primary objective of the IMS III Trial is to determine if ischemic stroke subjects with a baseline NIHSS scores 10, or with an NIHSSSof 8-9 with evidence of MCA, ICA, or basilar artery occlusion by CTA, treated with the combined IV+IA approach started within 3 hours of onset, are more likely to have a favorable outcome, defined as a modified Rankin Scale score of 0-2 assessed at 90 days from randomization, as compared to subjects treated with standard IV rt-PA. The two treatment groups also are compared with regard to additional clinical outcome measures, imaging, and safety data. In addiiton, cost effectiveness of the combined IV+IA approach is evaluated. The Trial currently is supported by two NINDS cooperative agreement grants: (1) to the University of Cincinnati Clinical Coordinating and Angiographic Imaging Center (PI: Joseph P. Broderick, MD) to provide clinical leadership and project and site management; and (2) to the Statistical and Data Coordinating Center (SDCC) at the Medical University of South Carolina (PI: Yuko Y. Palesch, PhD) to provide data management and statistical expertise. The purpose of this competitive renewal application from the SDCC is to closely collaborate with the Trial investigators to bring the IMS III Trial to successful completion with data quality of the highest standard.