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.
The ANGEL-BAO is a multicentered, prospective, randomized, open-label, blinded end-point clinical trial. A total of 224 patients with acute basilar artery occlusion with extended time window of 24-72 hours from onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups (endovascular treatment or medical management) after offering informed content.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
224
Best 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
The 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
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGRate 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.
Time frame: 90±14 days after randomization
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.
Time frame: 90±14 days after randomization
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.
Time frame: 90±14 days after randomization
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.
Time frame: 24 hours after randomization
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.
Time frame: 7 days after randomization or at discharge
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Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after randomization
EuroQol Five Dimensions (EQ-5D) is a standardized instrument for measuring the general health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
Time frame: 90±14 days after randomization
Proportion of basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA or MRA)
Basilar artery recanalization is defined as grade 2-3 of arterial occlusive lesion (AOL) scale. The AOL Score was defined as: 0=no recanalization of the primary occlusion, 1=incomplete or partial recanalization of the primary occlusion with no distal flow, 2=incomplete or partial recanalization of the primary occlusion with distal flow, or 3=complete recanalization of the primary occlusion with distal flow.
Time frame: 18-36 hours after randomization