NCT03754738Unknown2 期
Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients
Capital Medical University6 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2018年11月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 155
- 试验地点
- 6
- 主要终点
- Distal embolization,
研究概览
简要总结
With mechanical thrombectomy now representing standard of care for treatment of acute ischemic stroke secondary to large vessel occlusion, identifying adjunctive techniques that result in improved outcomes for patients with LVO has become an issue of increasing importance. A number of retrospective studies have demonstrated that flow arrest during the clot retrieval process results in less clot fragmentation, lower rates of distal emboli, higher revascularization rates and improved rates of good neurological outcome.
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
- Double (Care Provider, 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 or older
- •A clinical diagnosis of acute stroke, with a deficit on the NIHSS of 2 points or more.
- •Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA, or DSA.
- •Treatment can be initiated (groin puncture) within 6 hours of symptom onset.
- •Planning to mechanical thrombectomy with a stenting retriever.
- •Signed informed consent prior to entering study.
排除标准
- •Moderate stenosis, severe stenosis, or occlusion of the ipsilateral extracranial carotid artery.
- •Previously deployed stents in the ipsilateral carotid artery.
- •Dissections of the ipsilateral carotid artery.
- •Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.
- •Baseline platelet count < 50.000/µL.
- •Baseline blood glucose of < 50mg/dL or >400mg/dl.
- •Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg).
- •Renal insufficiency with creatinine ≥ 3 mg/dl.
- •Patients in sedation and intubated patients could not be included if baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation.
- •Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
- •Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
- •Subject participating in a study involving an investigational drug or device that would impact this study.
研究组 & 干预措施
Balloon guide catheter group
Experimental
mechanical thrombectomy with a balloon guide catheter group
干预措施: Balloon guide catheter (Device)
Non-balloon guide catheter group
Active Comparator
mechanical thrombectomy with a non-balloon guide catheter group
干预措施: Non-balloon guide catheter (Device)
结局指标
主要结局
Distal embolization,
时间窗: After mechanical thrombectomy, usually within 3 hours
次要结局
- Number of passes(After mechanical thrombectomy, usually within 3 hours)
- National Institutes of Health Stroke Scale(7 days or discharge)
- Modified Rankin Scale(90 days)
- Modified thrombolysis in cerebral infarction 2b/3 after the first pass(After the first pass, , usually within 3 hours)
- First pass recanalization rate(After the first pass, , usually within 3 hours)
- Modified thrombolysis in cerebral infarction 2b/3,(After mechanical thrombectomy, usually within 3 hours)
- Modified thrombolysis in cerebral infarction(After mechanical thrombectomy, usually within 3 hours)
- Procedure time(From the procedure start to the end, usually within 3 hours)
- Symptomatic intracranial hemorrhage(24 hours)
- Mortality(90 days)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University
研究点 (6)
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