Endovascular Recanalization and Standard Medical Management for Symptomatic Non-acute Intracranial Artery Occlusion: Study Protocol for a Non-randomized, 24-Month, Multicenter Study

Huijun Zhang, Jianjia Han, Xuan Sun, Zhongrong Miao, Xu Guo, Guodong Xu, Yaxuan Sun, Chao Wen, Chaobin Wang, Yingchun Wu, Yaoming Xu, Yuanfei Jiang, Shiyong Zhang, Chao Liu, Di Li, Yan Liu, Chenghua Xu, Feng Gao, Huijun Zhang, Jianjia Han, Xuan Sun, Zhongrong Miao, Xu Guo, Guodong Xu, Yaxuan Sun, Chao Wen, Chaobin Wang, Yingchun Wu, Yaoming Xu, Yuanfei Jiang, Shiyong Zhang, Chao Liu, Di Li, Yan Liu, Chenghua Xu, Feng Gao

Abstract

Background: The management of patients with symptomatic non-acute intracranial artery occlusion (sNA-ICAO), which is a special subset with high morbidity and a high probability of recurrent serious ischemic events despite standard medical therapy (SMT), has been clinically challenging. A number of small-sample clinical studies have also discussed endovascular recanalization (ER) for sNA-ICAO; however, there is currently a lack of evidence from multicenter, prospective, large-sample cohort trials. The purpose of our present study was to evaluate the technical feasibility and safety of ER for sNA-ICAO. Methods: Our group is currently undertaking a multisite, non-randomized cohort, prospective registry study enrolling consecutive patients presenting with sNA-ICAO at 15 centers in China between January 1, 2020 and December 31, 2022. A cohort of patients who received SMT and a cohort of similar patients who received ER plus SMT were constructed and followed up for 2 years. The primary outcome is any stroke from enrollment to 2 years of follow-up. The secondary outcomes are all-cause mortality, mRS score, NIHSS score and cognitive function from enrollment to 30 days, 3 months, 8 months, 12 months, 18 months, and 2 years of follow-up. Descriptive statistics and linear/logistic multiple regression models will be generated. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat. Discussion: The management of patients with sNA-ICAO has been clinically challenging. The current protocol aims to evaluate the technical feasibility and safety of ER for sNA-ICAO. Trial Registration Number: www.ClinicalTrials.gov, identifier: NCT04864691.

Keywords: endovascular recanalization; major and mild stroke; primary and secondary outcomes; standard medical therapy; symptomatic non-acute intracranial artery occlusion.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Zhang, Han, Sun, Miao, Guo, Xu, Sun, Wen, Wang, Wu, Xu, Jiang, Zhang, Liu, Li, Liu, Xu and Gao.

Figures

Figure 1
Figure 1
sNA-ICAO diagnosed by DSA. (A) Illustrations of non-acute occlusion of intracranial segment of internal carotid artery; (B) recanalization after endovascular treatment; (C) illustrations of non-acute occlusion of middle cerebral artery; (D) recanalization after endovascular treatment.
Figure 2
Figure 2
Flowchart of the trial design.

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