The Efficacy and Safety of Endovascular Therapy for Acute Ischemic Stroke Due to Large Core Infarction -- A Multicenter, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 308
- 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
This study assesses the efficacy and safety of endovascular therapy in patients with acute basilar artery occlusion with large core infarction within a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial
详细描述
This is a prospective, randomized, open-label, controlled trial designed to compare 90-day clinical outcomes between endovascular therapy (EVT) and best medical management (BMM) in patients with acute posterior circulation large vessel occlusion (LVO) and large core infarction. Eligible patients, aged 18 to 80 years presenting within 24 hours of symptom onset or last known well, must have imaging-confirmed acute basilar artery occlusion and large core infarction, defined as a pc-ASPECTS ≤5 or a Pons-midbrain-index (PMI) ≥ 3 on NCCT or DWI. Participants will be randomly assigned (1:1) to receive EVT or BMM. The primary outcome is functional independence at 90 days, assessed by the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-3. Secondary outcomes include the distribution of mRS scores at 90 days, 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH)
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age ranged from 18 to 80 years
- •Acute ischemic stroke in posterior circulation, the time from stroke onset (or finally found normal) to randomization was within 24 hours
- •Acute basilar artery occlusion confirmed by CTA,MRA,or DSA
- •Posterior circulation large core infarction:NCCT or DWI showed pc-ASPECTS≤5, or Pons-Midbrain Index (PMI)≥3
- •NIHSS score ≥10 before randomization
- •Pre-stroke mRS of 0-2
- •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
- •Known or highly suspected chronic occlusion of basilar artery
- •History of contraindication for contrast medium (except mild rash)
- •Current pregnant or breast-feeding
- •Refractory hypertension (defined as systolic blood pressure>220 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment;
- •Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
- •It is known that patients with dementia or mental illness cannot complete neurological function assessment and follow-up
- •Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.)
- •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
- •CTA/MRA/DSA confirmed occlusion of anterior and posterior circulation
- •Central nervous system vasculitis has been diagnosed or clinically suspected
- •Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.7
- •Blood glucose<2.7 or>22.2 mmol/L; Platelet count<50×109/L, glomerular filtration rate<30ml/min or serum creatinine ≥ 3 mg/dl
- •Acute cerebral infarction occurred within 48 hours after cardio cerebral vascular intervention or major surgery (patients over 48 hours can be included in the group)
研究组 & 干预措施
Endovascular Treatment Group
Participants randomized to the endovascular recanalization arm will receive endovascular treatment in addition to best medical management. The procedure aims to achieve recanalization of the occluded posterior circulation vessel using mechanical thrombectomy techniques, including stent retriever and/or aspiration-based approaches. When necessary, adjunctive endovascular measures may be performed as rescue therapy at the discretion of the treating neurointerventionalist.
干预措施: Endovascular Recanalization Strategy (Procedure)
Best Medical Management Group
Participants randomized to this arm will receive best medical management alone, consistent with current guideline recommendations for the acute and secondary prevention phases of ischemic stroke. No endovascular recanalization procedures are permitted after randomization.
干预措施: Best Medical Management (Drug)
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)
- The proportion of Barthel Index ≥ 95 at 90 (± 14) days after randomization(90±14 days after randomization)
- Basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA, MRA, DSA or TCD)(18-36 hours after randomization)
- Technical success rate, defined as successful recanalization of target vessels at the end of surgery (eTICI 2b-3)(At the end of the operation)
- The proportion of mRS 0-4 at 90 (± 14) days after randomization(90±14 days after randomization)
研究者
Feng Gao
Vice-Director of Interventional Neuroradiology, Department of Neurology
Beijing Tiantan Hospital