Efficacy and Safety of a Dedicated Device for Cerebral Venous Thrombectomy: A Pilot Randomized Clinical Trial.

BACKGROUND

Lack of a dedicated thrombectomy device for cerebral venous thrombosis hinders the recanalization ability of endovascular treatment (EVT). Novel NiTi-braided stent retriever (Venous-TD) is a dedicated venous sinus thrombectomy device. This study aims to demonstrate the safety and efficacy of Venous-TD.

METHODS

In this pilot, prospective, randomized, single-blind, parallel-group control, single-center clinical study, patients with cerebral venous thrombosis from Beijing Xuanwu Hospital were included. Randomization was performed to EVT with either the Venous-TD or Angioguard with Sterling balloon (control group). The primary efficacy outcome was the proportion of immediate complete recanalization during EVT. Secondary outcomes included the proportion of functional independence and moderate to severe residential headache at 180 days after EVT. Safety outcomes included peri-procedural complications, all-cause mortality, and symptomatic intracranial hemorrhage after EVT.

RESULTS

A total of 61 patients were enrolled and randomized. Thirty-one patients were randomized to the Venous-TD group, and 30 were randomized to the control group. The median (interquartile range) age was 28 (21-45) in the Venous-TD group and 34 (24-43) in the control group. The proportion of patients with a National Institutes of Health Stroke Scale score >8 on admission was 8 (25.8%) in the Venous-TD group and 11 (36.7%) in the control group. During EVT, Venous-TD significantly improved the proportion of complete recanalization compared with Angioguard (23 [76.7%] versus 6 [20.0%]; relative risk, 3.833 [95% CI, 1.825-8.054]). The proportions of long-term functional independence at 180 days in the Venous-TD group and the control group were not significantly different. The proportion of patients with severe residual headache at 180 days in the Venous-TD group was significantly lower than that in the control group (3 [9.7%] versus 10 [35.7%]; relative risk, 0.271 [95% CI, 0.083-0.886]). Safety outcomes showed no statistically significant difference between the 2 groups.

CONCLUSIONS

This trial indicated that Venous-TD did not increase complications in EVT of cerebral venous thrombosis and can significantly increase the proportion of complete recanalization. A multicenter phase III randomized control trial assessing efficacy and safety of Venous-TD is warranted.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT05291585.