Background

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).

Objective

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.

Methods

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.

Results

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.

Conclusion

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.

中文翻译：

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新的支架检索器Tron FX用于近端和远端颅内大血管闭塞的临床试验

背景

在所有机械血栓切除术的随机对照试验中，目标血管均位于近端。本文中，我们报告了Tron FX支架取回器的临床试验，包括颅骨远端大血管闭塞（LVO）的最小尺寸为2/15 mm。

目的

符合条件的患者在发病后8小时内出现近端或远端LVO，并将Tron FX 4/20 mm或2/15 mm作为第一线设备。

方法

主要终点是仅使用Tron FX后立即进行2a–3级脑梗死（mTICI）改良溶栓治疗的比率，死亡率为90 d。我们比较了尺寸4/20和2/15 mm之间的结果。

结果

进行了50例临床试验，其中44％的患者远端LVO，15例仅使用Tron FX 2/15 mm治疗。mTICI 2a–3级的总发生率为80.0％（Tron FX 4/20 mm为75.8％，2/15 mm为86.7％），改良的Rankin Scale≤2或改善了美国国立卫生研究院，为90天66.7％的病例在血栓切除术≥10后达到了卒中规模（Tron FX 4/20 mm为61.3％，2/15 mm为80.0％）。90天总死亡率为8.0％，2.0％的病例在24小时内出现症状性颅内出血。

结论

在这项使用Tron FX的临床试验中，其远端LVO的尺寸为2/15 mm，与以前的研究相比，其疗效相似且安全性更高。