Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan.
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan; Center for Clinical Research and Innovation, Kobe City Medical Center General Hospital, Kobe, Japan.
J Stroke Cerebrovasc Dis. 2021 Mar;30(3):105585. doi: 10.1016/j.jstrokecerebrovasdis.2020.105585. Epub 2021 Jan 5.
In all of randomized controlled trials of mechanical thrombectomy, the target vessels were proximal. Herein we report a clinical trial of the Tron FX stent retriever, including the smallest size of 2/15 mm for distal intracranial large vessel occlusion (LVO).
Eligible patients presented within 8 h of onset with proximal or distal LVOs, and the Tron FX 4/20 mm or 2/15 mm were used as the first-line device.
The primary endpoints were rate of modified Thrombolysis in Cerebral Infarction (mTICI) grade 2a-3 immediately after using Tron FX only, and mortality rate 90 d. We compared the outcomes between sizes 4/20 and 2/15 mm.
The clinical trial was conducted in 50 cases, of which 44% presented with distal LVO and 15 cases were treated using only Tron FX 2/15 mm. The overall rate of mTICI grade 2a-3 was 80.0% (75.8% with Tron FX 4/20 mm, and 86.7% with 2/15 mm), and a 90-day modified Rankin Scale ≤ 2 or improvement of National Institute of Health Stroke Scale after thrombectomy ≥ 10 was achieved in 66.7% of cases (61.3% with Tron FX 4/20 mm, and 80.0% with 2/15 mm). The overall 90-day mortality rate was 8.0%, and symptomatic intracranial hemorrhage within 24 h occurred in 2.0% of cases.
In this clinical trial using the Tron FX, which included the size of 2/15 mm for distal LVO, its efficacy was similar and its safety was superior compared with previous studies.
在所有机械取栓的随机对照试验中，目标血管均为近端血管。在此，我们报告了一项 Tron FX 支架取栓器的临床试验，其中包括最小尺寸为 2/15mm 的远端颅内大血管闭塞（LVO）。
符合条件的患者在发病后 8 小时内出现近端或远端 LVO，首先使用 Tron FX 4/20mm 或 2/15mm 作为一线设备。
主要终点为仅使用 Tron FX 即刻后改良脑梗死溶栓（mTICI）分级 2a-3 的比例，以及 90 天死亡率。我们比较了 4/20mm 和 2/15mm 两种尺寸的结果。
该临床试验共纳入 50 例患者，其中 44%为远端 LVO，15 例仅使用 Tron FX 2/15mm 治疗。总体 mTICI 分级 2a-3 的比例为 80.0%（Tron FX 4/20mm 为 75.8%，2/15mm 为 86.7%），90 天改良 Rankin 量表评分≤2 或国立卫生研究院卒中量表评分在取栓后提高≥10 的比例为 66.7%（Tron FX 4/20mm 为 61.3%，2/15mm 为 80.0%）。总的 90 天死亡率为 8.0%，24 小时内症状性颅内出血发生率为 2.0%。
在这项使用 Tron FX 的临床试验中，包括了远端 LVO 的 2/15mm 尺寸，其疗效与既往研究相似，安全性更优。
