THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 64
- 主要终点
- Efficacy Endpoint: Angiographic Revascularization
研究概览
简要总结
The objective of this study is to demonstrate the safety and efficacy of the Penumbra System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age 18 - 80 years
- •Treatment within 8 hours of symptom onset
- •Pre-stroke mRS 0-2
- •Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion in the internal carotid, middle cerebral (M1 or M2), basilar, or vertebral artery
- •If patient is eligible for thrombolytic therapy, it was administered as soon as possible, and no later than 3 hours from stroke symptom onset
- •Planned frontline treatment with Penumbra System including Thunderbolt modulated aspiration
- •Informed consent obtained per Institution Review Board/Ethics Committee requirements
排除标准
- •Stenosis, excessive tortuosity, or any occlusion in a proximal vessel requiring treatment or preventing access to the thrombus
- •Alberta Stroke Program Early CT Score (ASPECTS) ≤6 or core infarct volume >50 mL on MRI or CT-based imaging (for anterior circulation strokes)
- •Pregnant patient
- •Life expectancy < 90 days due to comorbidities
- •Current participation in an interventional drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies
- •Other medical, behavioral, or psychological conditions that in the opinion of the Investigator could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
研究组 & 干预措施
Single Arm
Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy
干预措施: Mechanical Thrombectomy (Penumbra System with Thunderbolt) (Device)
结局指标
主要结局
Efficacy Endpoint: Angiographic Revascularization
时间窗: Immediate Post Procedure
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by mTICI 2b or higher. \*mTICI ranges from 0-3, with higher grading representing better outcome
次要结局
- Efficacy Endpoint: Modified Rankin Scale (mRS)(90 Days Post-Procedure)
- Efficacy Endpoint: Angiographic Revascularization After First Pass(Index Procedure)
- Efficacy Endpoint: Angiographic Revascularization(Immediate Post Procedure)
- Efficacy Endpoint: Time to Revascularization(Index Procedure)
- Safety Endpoint: Serious Adverse Events (SAEs)(Up to 24 hours Post-Procedure)
- Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)(24 hours Post-Procedure)
- Safety Endpoint: All-cause mortality(90 Days Post-Procedure)