Evaluation of the Penumbra™ Stroke System in the Revascularization of Patients With Acute Ischemic Stroke Secondary to Intracranial Large Vessel Occlusive Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Device-related and Procedure-related Serious Adverse Events
研究概览
简要总结
This clinical evaluation is a prospective, single-arm, multi-center trial.
The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.
详细描述
Purpose:
The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease. Up to 125 evaluable patients will be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs consistent with acute ischemic stroke
- •18 to 79 years of age
- •Neurological deficit resulting in an NIH Stroke Scale (NIHSS) score > 8
- •TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System
- •Signed informed consent
- •Present within 8 hours of stroke symptom onset; ineligible or refractory to intravenous tissue plasminogen activator (t-PA) therapy if presenting within 3 hours of symptom onset.
排除标准
- •Evidence of rapidly improving neurological signs of stroke at time of enrollment
- •NIHSS > 30 or coma
- •Females who are pregnant
- •Vessel tortuosity too difficult to allow endovascular access
- •Known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an International Normalized Ratio (INR) > 3.0
- •Partial thromboplastin time (PTT) greater than 2 times the lab normal
- •Admission platelets < 30,000
- •Pre-existing neurological or psychiatric disease that could confound the study results
- •Known severe allergy to contrast media
- •Uncontrolled hypertension
- •Computed tomography (CT) evidence of significant mass effect with a midline shift
- •CT reveals evidence of large hypodensity region > 1/3 of the middle cerebral artery territory
- •CT reveals evidence of intracranial hemorrhage
- •CT reveals significant mass effect with midline shift
- •Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal
- •Angiographic evidence of preexisting arterial injury
- •Life expectancy of less than 90 days
- •Participation in another clinical investigation that could confound the evaluation of the study device.
结局指标
主要结局
Percentage of Participants With Device-related and Procedure-related Serious Adverse Events
时间窗: 3-Month Post-Procedure
Percentage of Participants With Revascularization of the Occluded Target Vessel
时间窗: 3-Month Post-Procedure
Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System. TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.
次要结局
- Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment(90-Day)
- Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment(Discharge or 30-Days Post-Procedure)
- Percentage of Participants With All Cause Mortality(90-Days Post-Treatment)
- Percentage of Participants With Symptomatic Hemorrhage(24-Hour Post-Procedure)