Basilar Artery Occlusion Chinese Endovascular Trial: Protocol for a prospective randomized controlled study

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.