ThrombX Retriever for Acute Ischemic Stroke Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Successful reperfusion of the occluded target vessel with up to 3 passes of the ThrombX Retriever
研究概览
简要总结
This trial is designed to assess the safety and effectiveness of the ThrombX Retriever.
详细描述
This trial is a clinical evaluation is to assess the safety and effectiveness of the ThrombX Retriever in the revascularization of the site of primary occlusion in patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute anterior circulation ischemic stroke
- •Pre-stroke Modified Rankin Score ≤ 1
- •NIHSS ≥ 6 and < 25 immediately prior to enrollment
- •ASPECT score ≥6 with CT scanning or core infarct volume <50 mL on magnetic MRI or CT based perfusion imaging
- •Occlusion of IC or the middle cerebral artery M1 or M2 division
- •Subject can be treated within eight-hours of onset of stroke symptoms
排除标准
- •Pregnant or lactating at time of admission
- •Known serious sensitivity to radiographic contrast agents
- •Known sensitivity to nickel, titanium metals, or their alloys
- •Current participation in another investigation drug or device treatment study
- •Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency prothrombin time lab results to be available prior to enrollment)
- •Renal failure
- •Baseline blood glucose of <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L)
- •Baseline platelet count < 50,000/uL
- •Severe, sustained hypertension
- •Presumed septic embolus, suspicion of bacterial endocarditis
- •Subject has a contraindication to an angiogram
- •Life expectancy <6 months
- •Comorbid disease or condition that would confound assessments
- •Known history of arterial tortuosity, preexisting stent, and/or other arterial disease
- •Tandem lesions, occlusion requiring angioplasty and/or stent placement or evidence of carotid dissection
- •Site of occlusion is heavily calcified
- •Imaging or clinical evidence of bilateral strokes or concomitant posterior circulation stroke
- •CT or MRI evidence of hemorrhage or evidence of mass effect or intra-cranial tumor
- •Imaging evidence suggests subject is not appropriate for mechanical thrombectomy
结局指标
主要结局
Successful reperfusion of the occluded target vessel with up to 3 passes of the ThrombX Retriever
时间窗: Up to the end of theprocedure
Defined by a mTICI score \>2b
Safety Endpoint
时间窗: 24 hours
Symptomatic intracerebral hemorrhage (sICH) confirmed on imaging and other Serious Adverse Device Effects (SADE) within 24 hours post procedure. The sICH is defined as the presence of extravascular blood in the cranium associated with an increase in the NIHSS score of ≥ 4 points or death.
次要结局
- Functional independence defined by modified Rankin Scale (mRS)(90 Days)