The Efficacy and Safety of Endovascular Treatment for Acute Mild Basilar Artery Occlusion: A Multicenter, Prospective, Open-Label, Endpoint-Blinded, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- The rate modified Rankin Scale (mRS) score 0-2 at 90 days
研究概览
简要总结
This study assesses the efficacy and safety of endovascular treatment for acute mild basilar artery occlusion within a multicenter, prospective, open-label, endpoint-blinded, randomized controlled clinical trial.
详细描述
This is a multicenter, prospective, randomized, open-label, controlled trial with blinded outcome assessment (PROBE design) evaluating endovascular therapy (EVT) for patients with acute mild basilar artery occlusion (MBAO). Acute MBAO is defined as basilar artery occlusion confirmed by CTA/MRA/DSA, with mild neurological deficits (baseline NIHSS ≥2 and <10). Participants will be randomized in a 1:1 ratio to receive either EVT plus best medical therapy or best medical therapy alone. The primary outcome is the rate of good functional status at 90 days after randomization was defined as the modified Rankin Scale (mRS) score of 0-2 at 90 days. 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •NIHSS score≥2 points and<10 points from the onset of the disease to before randomization
- •Posterior circulation large core infarction:NCCT or DWI showed pc-ASPECTS≥6, or Pons-Midbrain Index (PMI)<3
- •No significant functional disability before stroke (mRS≤2 points)
- •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)
- •CTA/MRA/DSA confirmed occlusion of anterior and posterior circulation
- •Severe stenosis, arterial dissection, or excessive tortuosity of the extracranial or intracranial segments of the vertebral artery may result in the inability of interventional instruments to be successfully delivered or positioned
- •Current pregnant or breast-feeding
- •Refractory hypertension (defined as systolic blood pressure>185 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment
- •Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.5
- •Blood glucose<2.8 or>22.2 mmol/L; Platelet count<100*109/L, serum creatinine>2.0 g/L (177 μ mol/L), or glomerular filtration rate<30 ml/(min*1.73 m2)
- •Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months
- •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)
- •Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.)
- •Central nervous system vasculitis has been diagnosed or clinically suspected
- •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
- •Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
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 basilar artery 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
The rate modified Rankin Scale (mRS) score 0-2 at 90 days
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 days after randomization(90±14 days after randomization)
- The rate of 0-1 and 0-3 mRS scores after randomization for 90 days(90±14 days after randomization)
- National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization(24 (-6/+12) hours after randomization)
- NIHSS score at 7 days after randomization or discharge (whichever occurs first), as well as changes from baseline(7 days after randomization or at discharge)
- European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score 90 days after randomization(90±14 days after randomization)
- Barthel index 95-100 points 90 days after randomization(90±14 days after randomization)
- The recanalization of the basilar artery 24 hours after randomization (confirmed by CTA, MRA, DSA, or TCD)(24 (-6/+12) hours after randomization)
- The technical success rate is defined as the successful recanalization of the target vessel at the end of the surgery (Extended Thrombolysis Classification for Cerebral Infarction [eTICI] 2b-3)(At the end of the operation)
研究者
Feng Gao
Vice-Director of Interventional Neuroradiology, Department of Neurology
Beijing Tiantan Hospital