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
This trial aims to evaluate the hypothesis that mechanical thrombectomy is superior to medical management alone in achieving favorable outcomes in subjects presenting with stroke due to basilar artery occlusion in the extended time window of 24-72 hours from symptom onset or time last seen well. In this trial, the randomization will employ a 2:1 ratio of mechanical thrombectomy versus best medical management alone. Randomization will be stratified according to age (18-70 or \>70), baseline NIHSS (6-20 or \>20) and therapeutic window (24-48 hours or \>48 hours). For the primary endpoint, subjects will be followed for 90 days post-randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
309
Neurointerventionist determine whether to proceed with interventional therapy after assessing the location and degree of occlusion, the tortuosity of the access vessel, and the presence of stenosis or occlusion in the proximal artery. In cases where there is no proximal stenosis or occlusion, mechanical thrombectomy is performed, and the specific thrombectomy strategy is tailored by the researcher based on the patient's condition. For lesions associated with proximal vascular stenosis or occlusion, it is necessary to navigate the catheter through the proximal stenosis or occlusion to access the intracranial occlusion. Researchers have the discretion to treat the stenotic or occluded vessels, which may include options such as no treatment, stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.
Xuanwu hospital
Beijing, Beijing Municipality, China
RECRUITINGDifference 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 \[death\])
Time frame: 90 days
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.
Time frame: 24 (-2/+12) hours
Dichotomized mRS score (0-2 versus 3-6 )
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 90 days
Ordinal Shift analysis of mRS at 90 days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 90 days
Barthel Index at 90 days
An ordinal scale which measures a person's ability to complete activities of daily living (ADL).
Time frame: 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.
Time frame: 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 \[death\])
Time frame: 12 months
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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 \[death\])
Time frame: 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.
Time frame: 24-72 hours (both treatment groups); post procedure immediately (thrombectomy arm)