Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window -- A Multicenter, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial（ANGEL-BAO）
Beijing Tiantan Hospital
224 participants
Oct 15, 2023
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria8
- Age≥18 years
- Acute basilar artery occlusion confirmed by CTA, MRA, or DSA
- Pre-stroke mRS of 0-2
- NIHSS score ≥ 10 before randomization
- Time interval from symptom onset (or last known well) to randomization within 24-72 hours
- Diffusion-weighted imaging(DWI)-based pc-ASPECTS ≥ 6 and Pons-Midbrain Index (PMI) ≤3
- Time from completion of DWI imaging to randomization is ≤3 hours
- Each patient or their legal representative must provide written informed consent before enrolment
Exclusion Criteria10
- 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
- History of contraindication for contrast medium (except mild rash)
- Current pregnant or breast-feeding
- Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
- Life expectancy is less than 3 months
- Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months.
- Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
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Interventions
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
Locations(1)
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NCT06101667