About this trial
The aim of this study is to assess the efficacy and safety of endovascular treatment versus medical management in patients with acute basilar artery occlusion with extended time window of 24-72 hours from onset.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years
Acute basilar artery occlusion confirmed by CTA, MRA, or DSA
Pre-stroke mRS of 0-2
NIHSS score ≥ 10 before randomization
Disqualifiers
Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization
Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging
CT or MRI evidence of intracranial tumor (except small meningioma and cerebral aneurysm < 3mm in diameter)
Known or highly suspected chronic occlusion of basilar artery
Trial design
Parallel
Treatments tested in this trial
Best medical management
DrugBest medical management included assessment of vital signs and neurological deficits,airway protection respiratory support,circulation;blood pressure monitoring;nutritional support;complication control;symptomatic treatment;laboratory and imaging examinations;etiological analysis and evaluation; anti platelet(e.g. aspirin,adenosine diphosphate (ADP) receptor inhibitors,Adenosine reuptake inhibitors,Glycoprotein platelet inhibitors);anticoagulation(e.g. warfarin, rivaroxaban,dabigatran,apixaban,edoxaban);lipid lowering(e.g. Statins,Fibrates);control of blood pressure(e.g. Thiazide diuretics,Potassium-sparing,Loop diuretic,Beta-blockers,Angiotensin II receptor blockers,Calcium channel blockers,Alpha blockers,Central alpha-2 receptor agonists);control of blood glucose(e.g. SULFONYLUREAS (SFUs),GLINIDES,BIGUANIDES,ALPHA-GLUCOSIDASE INHIBITORS: STARCH BLOCKERS,THIAZOLIDINEDIONES,GLP-1 ANALOGS,DPP-4 INHIBITORS,SGLT2 inhibitors); control of other risk factors
Endovascular treatment
Procedure/SurgeryThe strategies that were used for endovascular treatment included :stent retrievers (e.g., Solitaire® \[Medtronic, USA\], Trevo® \[Stryker, USA\], EMBOTRAP® \[Johnson \& Johnson, USA\], Captor® \[HeartCare, China\] and other stent-retriever systems) thromboaspiration (e.g., Penumbra® \[Penumbra, USA\], Afentta® \[HeMo, China\] and other aspiration systems)) balloon angioplasty (e.g., Gateway® \[Stryker, USA\], Neuro RX® \[SinoMed, China\], FocuStar® \[HeMo, China\] and other intracranial balloon catheter systems) stent deployment (e.g., Wingspan® \[Stryker, USA\], Apollo® \[MircoPort, China\], Enterprise® \[Johnson \& Johnson, USA\], Neuroform EZ® \[Stryker, USA\] and other Intracranial stent systems)) intraarterial thrombolysis (with alteplase or urokinase) combinations of above approaches that were left to the discretion of the treating team
Treatment groups
Trial outcomes
Primary outcomes
Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
Secondary outcomes
MRS score as an ordinal scale at 90 (±14) days after randomization
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
Rate of mRS 0-2 at 90 (±14) days after randomization
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization
The National Institute of Health Stroke Scale(NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
NIHSS score at 7 days after randomization or discharge (whichever came first)
The National Institute of Health Stroke Scale(NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Other outcomes
Rate of any Symptomatic intracranial hemorrhage (SICH) defined as the Heidelberg classification within 18-36 hours of randomization
Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below: 4 points total NIHSS at the time of diagnosis compared to immediately before worsening. 2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention. Absence of alternative explanation for deterioration.
Rate of any Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours after randomization
Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours
All cause of mortality within 7 days after randomization
All cause of mortality within 7 days after randomization
All cause of mortality within 90 (±14) days after randomization
All cause of mortality within 90 (±14) days after randomization
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