The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study
The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study
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DOI：
10.1136/neurintsurg-2019-014815
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发表时间：
2019-09-01
影响因子：
4.8
通讯作者：
Clajus, Stin
中科院分区：
文献类型：
--
作者：
Arthur, Adam S.;Molyneux, Andy;Clajus, Stin
介绍Woven EndoBridge囊内治疗（WEB-IT）研究是一项关键的、前瞻性的、单学科的、研究器械豁免研究，旨在评价WEB-IT器械治疗宽颈分叉动脉瘤的安全性和有效性。首次手术、6个月和1年随访访视的血管造影片均由核心实验室审查。所有不良事件均由临床事件裁定者进行审查和裁定。数据监测委员会在试验期间提供监督，以确保受试者safety.Results一百四十八名患者接受WEB植入。研究期间发生了1起（0.7%）主要安全性事件-术后第22天发生延迟性同侧脑实质损伤。30天至1年后未发生主要安全性事件。在12个月血管造影随访时，77/143例患者（53.8%）的动脉瘤完全闭塞。在121/143（84.6%）subjects.Conclusions达到了预先规定的安全性和有效性终点的WEB-IT试验中研究的动脉瘤。该试验的结果表明，WEB器械为宽颈分叉部动脉瘤患者提供了一种选择，与目前可用的治疗方法一样有效，而且明显更安全。
Introduction The Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, singlearm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms.Methods One-hundred and fifty patients with wideneck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety.Results One-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study-a delayed ipsilateral parenchymal hemorrhage-on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects.Conclusions The prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer.