1Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai.
2Department of Cerebrovascular Disease, Henan Provincial People's Hospital, Zhengzhou.
J Neurosurg. 2024 Jun 14;141(6):1697-1704. doi: 10.3171/2024.3.JNS232116. Print 2024 Dec 1.
Previous randomized controlled trials have reported a significantly higher occlusion rate of large and giant aneurysms when utilizing the Tubridge flow diverter (FD). In the present trial, the safety and efficacy of the Tubridge FD in treating unruptured internal carotid artery (ICA) or vertebral artery (VA) aneurysms were assessed in a real-world setting.
The Intracranial Aneurysms Managed by Parent Artery Reconstruction Using Tubridge Flow Diverter (IMPACT) study is a prospective, multicenter, single-arm clinical trial assessing the efficacy of the Tubridge FD in the management of unruptured aneurysms located in the ICA or VA. The primary endpoint was the complete occlusion (Raymond-Roy class 1) rate at the 1-year follow-up. The secondary endpoints included the technical success rate, the successful occlusion rate of the aneurysm, which is the degree of aneurysm embolization scored as Raymond-Roy class 1 or 2, major (> 50%) in-stent stenosis, and incidence of disabling stroke or neurological death associated with the target aneurysms.
This study included 14 interventional neuroradiology centers, with 200 patients and 240 aneurysms. According to angiographic core laboratory assessment, 205 (85.4%) aneurysms were located in the ICA, 34 (14.2%) in the VA, and 1 (0.4%) in the middle cerebral artery. Additionally, 189 (78.8%) aneurysms were small (< 10 mm). At the 12-month follow-up, the total occlusion rate was 79.0% (166/210, 95% CI 72.91%-84.34%). Additionally, the occurrence of disabling stroke or neurological death related to the specified aneurysms was 1% (2/200).
The 1-year results from the IMPACT trial affirm the safety record of use of the Tubridge FD in the treatment of intracranial aneurysms in real-world scenarios. These results reveal low morbidity and mortality rates of 3.5% and 1.5%, respectively. Furthermore, they provide evidence of the effectiveness of the Tubridge FD, as demonstrated by the complete occlusion achieved in 166 of 210 (79%) cases.
先前的随机对照试验报告称，使用 Tubridge 血流分流器（FD）时，大动脉瘤和巨大动脉瘤的闭塞率显著升高。在本试验中，在真实环境中评估 Tubridge FD 治疗未破裂颈内动脉（ICA）或椎动脉（VA）动脉瘤的安全性和有效性。
颅内动脉瘤通过使用 Tubridge 血流分流器重建母动脉管理（IMPACT）研究是一项前瞻性、多中心、单臂临床试验，评估 Tubridge FD 在管理位于 ICA 或 VA 的未破裂动脉瘤中的疗效。主要终点是 1 年随访时完全闭塞（Raymond-Roy 分级 1）率。次要终点包括技术成功率、动脉瘤的成功闭塞率，即动脉瘤栓塞程度评分为 Raymond-Roy 分级 1 或 2、支架内>50%狭窄、与目标动脉瘤相关的致残性中风或神经死亡的发生率。
本研究纳入了 14 个介入神经放射学中心的 200 名患者和 240 个动脉瘤。根据血管造影核心实验室评估，205 个（85.4%）动脉瘤位于 ICA，34 个（14.2%）位于 VA，1 个（0.4%）位于大脑中动脉。此外，189 个（78.8%）动脉瘤较小（<10mm）。在 12 个月的随访中，总的闭塞率为 79.0%（166/210，95%CI72.91%-84.34%）。此外，与指定动脉瘤相关的致残性中风或神经死亡的发生率为 1%（2/200）。
IMPACT 试验的 1 年结果证实了 Tubridge FD 在真实场景中治疗颅内动脉瘤的安全性记录。这些结果显示发病率和死亡率分别为 3.5%和 1.5%，均较低。此外，它们提供了 Tubridge FD 有效性的证据，在 210 例中有 166 例（79%）达到完全闭塞。
Zotero 插件