The Penumbra Pivotal Stroke Trial Safety and Effectiveness of a New Generation of Mechanical Devices for Clot Removal in Intracranial Large Vessel Occlusive Disease
The Penumbra Pivotal Stroke Trial Safety and Effectiveness of a New Generation of Mechanical Devices for Clot Removal in Intracranial Large Vessel Occlusive Disease
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DOI：
10.1161/strokeaha.108.544957
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发表时间：
2009-08-01
期刊：
影响因子：
8.3
通讯作者：
Gomes, Joao
中科院分区：
文献类型：
--
作者：
Langer, David;Alexander, Michael;Gomes, Joao
背景和目的-本临床评价的目的是评估Penumbra System在继发于颅内大血管闭塞性疾病的急性缺血性卒中患者血运重建中的安全性和有效性。方法-在本前瞻性、多中心、单组研究中，125例神经功能缺损患者（根据美国国立卫生研究院卒中量表评分>= 8，在症状发作8小时内出现，并且血管造影显示可治疗的颅内大血管闭塞（心肌梗死溶栓[TIMI] 0级或1级）。在症状发作后3小时内就诊的患者必须是重组组织型纤溶酶原激活剂治疗不合格或难治的患者。术后90天对所有患者进行临床随访。结果：125例患者的125条靶血管接受了Penumbra系统治疗。术后，81.6%的治疗血管成功实现了血管重建，达到TIMI 2 - 3级。16例患者（12.8%）报告了18起手术事件，3例患者（2.4%）发生了严重事件。共有35例患者（28%）在24小时CT上发现颅内出血，其中14例（11.2%）有症状。90天时全因死亡率为32.8%，25%的患者达到改良兰金量表评分
Background and Purpose-The purpose of this clinical evaluation was to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial large vessel occlusive disease.Methods-In this prospective, multicenter, single-arm study, 125 patients with neurological deficits as defined by a National Institutes of Health Stroke Scale score >= 8, presented within 8 hours of symptom onset, and an angiographic occlusion (Thrombolysis In Myocardial Infarction [TIMI] Grade 0 or 1) of a treatable large intracranial vessel were enrolled. Patients who presented within 3 hours from symptom onset had to be ineligible or refractory to recombinant tissue plasminogen activator therapy. All patients were followed clinically for 90 days postprocedure.Results-A total of 125 target vessels in 125 patients were treated by the Penumbra System. Postprocedure, 81.6% of the treated vessels were successfully revascularized to TIMI 2 to 3. There were 18 procedural events reported in 16 patients (12.8%), 3 patients (2.4%) had events that were considered serious. A total of 35 patients (28%) were found to have intracranial hemorrhage on 24-hour CT of which 14 (11.2%) were symptomatic. All cause mortality was 32.8% at 90 days with 25% of the patients achieving a modified Rankin Scale score of