Interventional Management of Stroke Phase III Trial - SDCC

描述（由申请人提供）：急性缺血性卒中的临床实践正处于关键时刻。FDA批准的除点装置的使用正在迅速扩大，未来几年将有更多的装置进入临床实践。 自2004年第一个FDA批准的用于治疗糖尿病的器械获得批准后，临床实践的这一重大变化加速了。 在急性卒中患者中进行血栓清除，并且在没有临床数据证明这些器械与标准治疗（发作后3小时内IV rt-PA）相比改善了患者结局的情况下进行。 正在进行的多中心卒中介入治疗（IMS）III期试验是唯一一项将标准治疗与IV rt-PA联合随后通过器械和/或IA rt-PA清除血栓的方法进行比较的随机III期试验。本试验的数据对于为临床和公共卫生政策决策提供关于急性缺血性卒中血管内治疗效果的信息至关重要。IMS III试验的主要目的是 确定基线NIHSS评分10分或NIHSS评分8-9分且CTA显示MCA、伊卡或基底动脉闭塞证据的缺血性卒中受试者，在发病3小时内开始接受IV+IA联合方法治疗，是否更有可能获得有利结局，定义为随机化后90天评估的改良兰金量表评分为0-2分，与接受标准IV rt-PA治疗的受试者相比。还比较了两个治疗组的其他临床结局指标、影像学和安全性数据。最后，对IV+IA组合方法的成本效益进行了评价。该试验目前由两项NINDS合作协议资助：（1）辛辛那提大学临床协调和血管造影成像中心（PI：Joseph P. Broderick，MD）提供临床领导和项目及研究中心管理;（2）南卡罗来纳州医科大学统计和数据协调中心（SDCC）（PI：Yuko Y. Palesch博士）提供数据管理和统计专业知识。SDCC的这一竞争性续期申请的目的是与试验研究者密切合作，以最高标准的数据质量成功完成IMS III试验。 公共卫生相关性：最近，FDA批准了越来越多的用于清除急性缺血性卒中患者血栓的器械，但迄今为止还没有研究表明这些器械可以改善患者的预后。IMS III试验的目的是明确确定，与目前仅使用静脉rt-PA的标准治疗相比，除了使用静脉rt-PA的当前标准治疗外，使用这些器械是否会导致更好的患者结局（在90天时评估）。

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. PUBLIC HEALTH RELEVANCE: Recently, the FDA has approved increasing number of devices to remove the clot in acute ischemic stroke patients, but no study to date has demonstrated that these devices improve patient outcomes. The purpose of the IMS III Trial is to definitively determine whether or not the use of these devices, in addition to the current standard treatment with intravenous rt-PA, results in better patient outcome (assessed at 90 days) compared to current standard treatment with intravenous rt-PA alone.