Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 44
- 主要终点
- modified Rankin Scale (mRS)
研究概览
简要总结
This trial will provide valuable insights into the safety and efficacy of endovascular treatment for acute ischemic stroke patients with basilar artery occlusion within 8 hours of estimated occlusion time.
详细描述
This clinical trial is designed to compare the safety and efficacy of endovascular treatment plus standard medical therapy with standard medical therapy alone for acute BA occlusion presented within 8 h of estimated occlusion time. There is only one ongoing clinical trial-Basilar Artery International Cooperation Study (BASICS) (NCT01717755) aimed to evaluate the efficacy and safety of additional intra-arterial treatment after intravenous treatment in 750 patients with BA occlusion, which was anticipated to be completed in Oct 2017. Initiation of intra-arterial therapy should be feasible within 6 hours of estimated time of BA occlusion. And patients are required to have an NIHSS ≥ 10 at time of randomization, and take IV rt-PA, age between 18-85 years old.
In this trial, the investigators did not have age or NIHSS score limit, patients who did not fulfill the requirements for IV rt-PA can also be included into the trial, the investigators also extended the time window to 8 hours which will accelerate the recruitment of potential subjects. In endovascular treatment arm, the time interval between randomization to procedure finish will be controlled within 120 mins. The preparation of endovascular treatment will start immediately after randomization for those eligible patients for IV rt-PA within 4.5 hours after acute stroke onset, with no need to wait for the one-hour rt-PA infusion. A positive trial will suggest substantial clinical benefit from endovascular treatment plus standard medical therapy over standard medical therapy. This trial may provide novel evidence of adopting endovascular treatment for acute patients with BA occlusion, which may consequently advance our current approach for acute stroke treatment.
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
- None
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 ischemic stroke consistent with infarction in the basilar artery territory;
- •Basilar artery occlusion confirmed by CTA/MRA/DSA, within 8 hours of estimated occlusion time;
- •Written informed consent from patient or surrogate, if unable to provide consent.
排除标准
- •Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of Cerebral hemorrhage on presentation;
- •Premorbid mRS ≥ 3 points;
- •Currently in pregnant or lactating;
- •Known serious sensitivity to radiographic contrast agents and nitinol metal;
- •Current participation in another investigation drug or device study;
- •Uncontrolled hypertension defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg that cannot be controlled except with continuous parenteral antihypertensive medication;
- •Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with INR >1.7 or institutionally equivalent prothrombin time;
- •Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets <100*109/L, or Hct<25%;
- •Arterial tortuosity that would prevent the device from reaching the target vessel;
- •Life expectancy less than 1 year;
- •History of major hemorrhage in the past 6 months;
- •Angiographic evidence of significant cerebellar mass effect or acute hydrocephalus.
- •Angiographic evidence of bilateral extended brainstem ischemia.
研究组 & 干预措施
standard medical therapy
Patients receive standard medical therapy alone.
干预措施: standard medical therapy (Other)
endovascular + standard medical therapy
Patients receive endovascular treatment plus standard medical therapy.
干预措施: endovascular treatment (Device)
endovascular + standard medical therapy
Patients receive endovascular treatment plus standard medical therapy.
干预措施: standard medical therapy (Other)
结局指标
主要结局
modified Rankin Scale (mRS)
时间窗: at 90 days from randomization
A score of 0-3 will be considered as the favorable outcome.
次要结局
- PC-ASPECT score on CT/MRI(at 24 hours from randomization)
- NIHSS score(at 5-7 days from randomization)
- mortality(at 3 months from randomization)
- mRS score 0-2(at 90 days from randomization)
- Change of mRS score(shift analysis)(at 90 days from randomization)
- Vessel recanalization rate evaluated by CT angiography or MRA(at 24 hours from randomization)
- GCS score(at 5-7 days from randomization)
- EuroQol 5D (EQ-5D)(at 90 days from randomization)
- symptomatic intracerebral hemorrhage (ICH)(within 24 hours from randomization)
- incidence of nonbleeding severe adverse events (SAEs)(within 90 days from randomization)
- severity of nonbleeding severe adverse events (SAEs)(within 90 days from randomization)
- incidence of procedure and device related complications(within 90 days from randomization)
- incidence of non-intracerebral hemorrhage complications(at 90 days from randomization)
- severity of non-intracerebral hemorrhage complications(within 90 days from randomization)
- severity of procedure and device related complications(within 90 days from randomization)
研究者
Xinfeng Liu
Professor and Chairman of Department of Neurology
Jinling Hospital, China