Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Int J Stroke. 2012 Dec;7(8):655-61. doi: 10.1111/j.1747-4949.2011.00719.x. Epub 2012 Jan 20.
Acute treatment of ischemic stroke patients presenting more than eight-hours after symptom onset remains limited and largely unproven. Partial aortic occlusion using the NeuroFlo catheter can augment cerebral perfusion in animals. We investigated the safety and feasibility of employing this novel catheter to treat ischemic stroke patients eight-hours to 24 h following symptom onset.
A multicenter, single-arm trial enrolled ischemic stroke patients at nine international academic medical centers. Eligibility included age 18-85 years old, National Institutes of Health stroke scale (NIHSS) score between four and 20, within eight-hours to 24 h after symptom onset, and perfusion-diffusion mismatch confirmed by magnetic resonance imaging. The primary outcome was all adverse events occurring from baseline to 30 days posttreatment. Secondary outcomes included stroke severity on neurological indices through 90 days. This study is registered with ClinicalTrials.gov, number NCT00436592.
A total of 26 patients were enrolled. Of these, 25 received treatment (one excluded due to aortic morphology); five (20%) died. Favorable neurological outcome at 90 days (modified Rankin score 0-2 vs. 3-6) was associated with lower baseline NIHSS (P < 0·001) and with longer duration from symptom discovery to treatment. There were no symptomatic intracranial hemorrhages or parenchymal hematomas. Asymptomatic intracranial hemorrhage was visible on computed tomography in 32% and only on microbleed in another 20%.
Partial aortic occlusion using the NeuroFlo catheter, a novel collateral therapeutic strategy, appears safe and feasible in stroke patients eight-hours to 24 h after symptom onset.
发病 8 小时后出现的缺血性脑卒中患者的急性治疗仍然有限且基本未经证实。使用 NeuroFlo 导管进行部分主动脉闭塞可以增加动物的脑灌注。我们研究了使用这种新型导管治疗发病 8 小时至 24 小时后的缺血性脑卒中患者的安全性和可行性。
一项多中心、单臂试验在 9 个国际学术医疗中心招募了缺血性脑卒中患者。入选标准包括年龄 18-85 岁、美国国立卫生研究院卒中量表（NIHSS）评分 4-20 分、发病后 8 小时至 24 小时内、磁共振成像确认灌注-弥散不匹配。主要结局是从基线到治疗后 30 天内发生的所有不良事件。次要结局包括 90 天内神经学指标的卒中严重程度。该研究在 ClinicalTrials.gov 注册，编号为 NCT00436592。
共纳入 26 例患者，其中 25 例接受了治疗（1 例因主动脉形态排除）；5 例（20%）死亡。90 天的良好神经学结局（改良 Rankin 评分 0-2 与 3-6）与较低的基线 NIHSS（P<0·001）和从症状发现到治疗的较长时间相关。无症状性颅内出血或脑实质血肿。32%的患者在计算机断层扫描上可见无症状性颅内出血，另有 20%的患者仅在微出血中可见。
NeuroFlo 导管进行部分主动脉闭塞，这是一种新的侧支治疗策略，在发病 8 小时至 24 小时后的脑卒中患者中似乎是安全且可行的。
