Department of Neurosurgery, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, New York, USA.
J Neurointerv Surg. 2014 Jun;6(5):363-72. doi: 10.1136/neurintsurg-2013-010794. Epub 2013 Jul 2.
Primary stenting for acute ischemic stroke (AIS) using the Wingspan stent delivery system has been reported. Major technical limitations in that study were difficulties in delivering the device and a few cases in which the Enterprise vascular reconstruction device (stent) was used as a bailout procedure. The Enterprise, which has relatively less radial force and more flexibility than other intracranial stents, is an ideal device for revascularization as it is easily delivered through tortuous intracranial vessels. We tested the safety and effectiveness of this stent as the primary revascularization device for AIS in an FDA-approved investigational device exemption prospective cohort study.
Twenty patients presenting with AIS due to confirmed intracranial large vessel occlusion within 8 h of onset of stroke symptoms were treated with the Enterprise as the primary revascularization device. The primary outcome was recanalization to Thrombolysis In Myocardial Infarction (TIMI) flow of ≥2. Perioperative safety was measured by major complication incidence within 30 days of stent revascularization. A secondary measure of outcome was 30-day modified Rankin Scale (mRS) score.
Recanalization to TIMI 2 (n=6) or 3 (n=12) flow was achieved in 18 patients (90% revascularization rate). Three major complications were noted (15%) including one myocardial infarction, one symptomatic intracranial hemorrhage and one ischemic stroke in a distribution other than the qualifying vessel. Good outcome (mRS ≤2) was obtained in 10 patients (50%).
In this prospective study the Enterprise stent was found to be a safe and effective revascularization tool in the setting of AIS.
已报道使用 Wingspan 支架输送系统对急性缺血性脑卒中（AIS）进行直接支架置入。该研究中的主要技术局限性为输送装置存在困难，并且有少数情况下使用 Enterprise 血管重建装置（支架）作为紧急补救措施。Enterprise 支架的径向力相对较小，柔韧性更强，优于其他颅内支架，是血管再通的理想装置，因为它可以轻松通过迂曲的颅内血管输送。我们在一项经过 FDA 批准的研究性器械豁免前瞻性队列研究中，测试了该支架作为 AIS 主要血管再通装置的安全性和有效性。
20 例 AIS 患者因发病 8 小时内出现的颅内大血管闭塞而接受 Enterprise 支架作为主要血管再通装置治疗。主要转归是血管再通至血栓溶栓（TIMI）血流≥2 级。围手术期安全性通过支架血管成形术后 30 天内主要并发症发生率进行测量。次要转归指标为 30 天改良 Rankin 量表（mRS）评分。
18 例患者（90%的再通率）实现 TIMI 2 级（n=6）或 3 级（n=12）血流再通。3 例出现主要并发症（15%），包括 1 例心肌梗死、1 例症状性颅内出血和 1 例除合格血管以外分布的缺血性脑卒中。10 例患者（50%）获得良好结局（mRS≤2）。
在这项前瞻性研究中，Enterprise 支架被发现是 AIS 血管再通的一种安全有效的治疗工具。
