Basilar Artery Occlusion Chinese Endovascular Trial in the Extended Time Window
NCT Number: NCT06560203
Acronym: BAOCHE2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Ischemic Stroke|Basilar Artery Occlusion
Interventions: PROCEDURE: Mechanical thrombectomy
Sponsor: Capital Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 309
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-16
Completion Date: 2026-06-30

Summary:
A prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial to evaluate the safety and efficacy of endovascular mechanical thrombectomy for acute basilar artery occlusion in the extended time window

Primary Outcome Measures: Difference in proportion of patients achieving favorable outcomes (defined as mRS 0-3) at 90 days, The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]), 90 days
Secondary Outcome Measures: Dramatic early favorable response, Dramatic early favorable response as determined by an National Institute of Health stroke scale (NIHSS) of 0-2 or NIHSS improvement ≥ 8 points at 24 (-2/+12) hours., 24 (-2/+12) hours|Dichotomized mRS score (0-2 versus 3-6 ), The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]), 90 days|Ordinal Shift analysis of mRS at 90 days, The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]), 90 days|Barthel Index at 90 days, An ordinal scale which measures a person's ability to complete activities of daily living (ADL)., 90 days|Quality of life analysis as measured by EuroQol Five Dimensions (EuroQol/EQ-5D), EuroQol Five Dimensions (EuroQol/EQ-5D) is a well-known and widely used health status instrument, and could be used to measure, compare and value health status across disease areas., 90 days|Difference in proportion of patients with mRS 0-2 scores between the two groups at 12 months., The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]), 12 months|Difference in proportion of patients with mRS 0-3 scores between the two groups at 12 months., The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]), 12 months|Proportion of basilar artery recanalization, Vessel recanalization evaluated by CT angiography (CTA), MR Angiography (MRA) or conventional angiography at 24-72 hours in both treatment groups assessed by Arterial Occlusive Lesion（AOL) grades and adjudicated by a central core-lab.

Vessel recanalization post procedure in the thrombectomy arm assessed by mTICI grades. Successful recanalization is defined as mTICI (Modified Thrombolysis in Cerebral Infarction) 2b or 3 on the post-procedure angiogram., 24-72 hours (both treatment groups); post procedure immediately (thrombectomy arm)
Other Outcome Measures: Mortality, Death, 90 days|Symptomatic intracranial hemorrhage, Clinically significant ICH rates at 24-72 hours. All intracerebral hemorrhages will be classified by a central core-lab using the Heidelberg criteria. Symptomatic intracranial hemorrhage will be defined as per the following definition: deterioration in NIHSS score of ≥ 4 points and evidence of intraparenchymal hemorrhage type 2 in the 24 to 72 hours follow-up imaging scans., 24-72 hours|Serious adverse events (SAE), All SAE during follow-up in all randomized patients., 90 days, 12 months, during follow-up