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）
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Best medical management
Patients randomly assigned to the control group should receive the best medical management according to the guidelines.
干预措施: Best medical management (Drug)
Endovascular treatment
Stent retrievers, thromboaspiration, balloon angioplasty, stent deployment, intra-arterial thrombolysis (Recombinant tissue plasminogen activator (rt-PA) or urokinase), or the various combinations of these approaches.
干预措施: Endovascular treatment (Procedure)
结局指标
主要结局
Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization
时间窗: 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.
次要结局
- MRS score as an ordinal scale at 90 (±14) days after randomization(90±14 days after randomization)
- Rate of mRS 0-2 at 90 (±14) days after randomization(90±14 days after randomization)
- National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization(24 hours after randomization)
- NIHSS score at 7 days after randomization or discharge (whichever came first)(7 days after randomization or at discharge)
- Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after randomization(90±14 days after randomization)
- Proportion of basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA or MRA)(18-36 hours after randomization)
研究者
Feng Gao
Vice-Director of Interventional Neuroradiology, Department of Neurology
Beijing Tiantan Hospital