Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook, New York, USA.
Oxford Neurovascular and Neuroradiology Research Unit, Oxford Radcliffe Hospital, Oxford, UK.
J Neurointerv Surg. 2017 Dec;9(12):1191-1196. doi: 10.1136/neurintsurg-2016-012841. Epub 2017 Jan 17.
The Woven EndoBridge (WEB) represents a novel intrasaccular therapeutic option for the treatment of intracranial wide-necked bifurcation aneurysms (WNBAs). The WEB-IT Study is a pivotal Investigational Device Exemption (IDE) study to determine the safety and effectiveness of the WEB device for the treatment of WNBAs located in the anterior and posterior intracranial circulations. We present the patient demographics, procedural characteristics, and 30-day adverse event data for the US WEB-IT study.
WEB-IT is a prospective multicenter single-arm interventional study conducted at 25 US and 6 international centers. The study enrolled 150 adults with WNBAs of the anterior and posterior intracranial circulations. All patients were intended to receive a WEB device delivered via standard endovascular neurosurgical embolization techniques. The study was conducted under Good Clinical Practices and included independent adjudication effectiveness outcomes and all adverse events.
One hundred and fifty patients enrolled at 27 investigational sites underwent attempted treatment with the WEB. Mean age was 59 years (range 29-79) and 110 (73.3%) of the patients were female. Treated aneurysms were located at the basilar apex (n=59, 39.3%), middle cerebral artery bifurcation (n=45, 30%), anterior communicating artery (n=40, 26.7%), and internal carotid artery terminus (n=6, 4%). Average aneurysm size was 6.4 mm (range 3.6-11.4) with a mean neck size of 4.8 mm (range 2.0-8.2, mean dome to neck ratio 1.34). Nine patients presented with ruptured aneurysms. Of the enrolled patients, 98.7% were treated successfully with WEB devices. Mean±SD fluoroscopy time was 30.2±15.7 min. One primary safety event (PSE) (0.7%)-a delayed parenchymal hemorrhage 22 days after treatment-occurred between the index procedure and 30-day follow-up. In addition to the single PSE, there were seven (4.7%) minor ischemic strokes (5 resolved without sequelae and 2 had a modified Rankin Scale score of 1 at 30 days), five (2.7%) transient ischemic attacks, and two (1.3%) minor subarachnoid hemorrhages, which did not meet the prospectively established criteria for PSEs.
The WEB device can be used to treat WNBAs with a high level of procedural safety and a high degree of technical success.
NCT02191618; Pre-results.
编织式腔内血管重建装置（WEB）是一种治疗颅内宽颈分叉部动脉瘤（WNBAs）的新型腔内治疗选择。WEB-IT 研究是一项关键的研究性器械豁免（IDE）研究，旨在确定 WEB 装置治疗前循环和后循环颅内 WNBAs 的安全性和有效性。我们介绍了美国 WEB-IT 研究的患者人口统计学、手术特点和 30 天不良事件数据。
WEB-IT 是一项在美国 25 个和 6 个国际中心进行的前瞻性多中心单臂介入研究。该研究纳入了 150 名患有前循环和后循环 WNBAs 的成年人。所有患者均计划使用标准的血管内神经外科栓塞技术接受 WEB 装置治疗。该研究在良好临床实践下进行，包括独立评估有效性结果和所有不良事件。
在 27 个研究点，150 名患者接受了 WEB 治疗尝试。平均年龄为 59 岁（范围 29-79 岁），110 名（73.3%）患者为女性。治疗的动脉瘤位于基底动脉顶端（n=59，39.3%）、大脑中动脉分叉处（n=45，30%）、前交通动脉（n=40，26.7%）和颈内动脉终末段（n=6，4%）。平均动脉瘤大小为 6.4mm（范围 3.6-11.4），平均颈部大小为 4.8mm（范围 2.0-8.2，平均瘤颈比为 1.34）。9 名患者出现破裂动脉瘤。纳入的患者中，98.7%的患者成功接受 WEB 装置治疗。平均±SD 透视时间为 30.2±15.7 分钟。1 例主要安全性事件（PSE）（0.7%）-治疗后 22 天出现迟发性实质内出血-发生在索引手术和 30 天随访之间。除了单一 PSE 外，还有 7 例（4.7%）小的缺血性中风（5 例无后遗症，2 例 30 天改良 Rankin 量表评分 1 分）、5 例短暂性脑缺血发作和 2 例小蛛网膜下腔出血，这些均不符合前瞻性确立的 PSE 标准。
WEB 装置可用于治疗宽颈分叉部颅内动脉瘤，具有较高的手术安全性和技术成功率。
NCT02191618；预结果。
