Basilar Artery Occlusion Chinese Endovascular Trial: Protocol for a prospective randomized controlled study
Chuanhui Li, Chuanjie Wu, Longfei Wu, Wenbo Zhao, Jian Chen, Ming Ren, Yao Chen, Xiaoyan Yan, Chongya Dong, Haiqing Song, Qingfeng Ma, Jiangang Duan, Yunzhou Zhang, Hongqi Zhang, Liqun Jiao, Yuping Wang, Tudor G. Jovin, Xunming Ji, on behalf of the BAOCHE Investigators
Abstract
RATIONALE: There are no randomized trials examining the best treatment for acute basilar artery occlusion in the 6-24-hour time window. AIMS: To assess the safety and efficacy of thrombectomy for stroke due to basilar artery occlusion in patients randomized within 6-24 h from symptom onset or time last seen well. SAMPLE SIZE: For an estimated difference of 20% in proportions of the primary outcome between the two groups, 318 patients will be included for 5% significance and 90% power with a planned interim analysis after two-thirds of the sample size (212 patients) have achieved the 90 days follow-up. METHODS AND DESIGN: A prospective, multi-center, randomized, controlled, open-label and blinded-endpoint trial. The randomization employs a 1:1 ratio of mechanical thrombectomy with the detachable Solitaire thrombectomy device and best medical therapy (BMT) vs. BMT alone. STUDY OUTCOMES: The primary outcome will be the proportion of patients achieving modified Rankin Scale (mRS) 0-3 at 90 days. Key secondary outcomes are: dramatic early favorable response, dichotomized mRS score (0-2 vs. 3-6 and 0-4 vs. 5-6) at 90 days, ordinal (shift) mRS analysis at 90 days, infarct volume at 24 h, vessel recanalization at 24 h in both treatment arms, and successful recanalization in the thrombectomy arm according to the modified thrombolysis in cerebral infarction (mTICI) classification defined as mTICI 2 b or 3. Safety variables are mortality at 90 days, symptomatic intracranial hemorrhage rates at 24 h, and procedure-related complications. DISCUSSION: URL: http://www.clinicaltrials.gov. ClinicalTrials.gov Identifier: NCT02737189.