i-RISE: International Acute Ischemic Stroke Study With the Penumbra System®
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Outcomes:
研究概览
简要总结
The primary objective of this study is to collect real-world performance and safety data on the Penumbra System in a patient population with acute ischemic stroke (AIS)
详细描述
Post-market, real-world, prospective, single-arm, multi-center study that will enroll up to 200 participants at up to 15 sites globally
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Pre-stroke mRS 0-1
- •Patients experiencing acute ischemic stroke who are eligible for mechanical thrombectomy using the Penumbra System
- •Frontline treatment with Penumbra System
- •Signed informed consent per Institution Review Board/Ethics Committee
排除标准
- •Alberta Stroke Program Early CT Score (ASPECTS) ≤6 (for anterior circulation strokes)
- •Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
- •Currently participating in an investigational (drug, device, etc.) clinical trial that will influence the endovascular procedure or acute treatment of the patient. Patients in secondary prevention, observational, natural history, and/or
- •epidemiological studies are eligible.
- •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
Patients with acute ischemic stroke (AIS)
Device: Penumbra System®
干预措施: Penumbra System ® (Device)
结局指标
主要结局
Outcomes:
时间窗: It is anticipated this study will take approximately 2 years. All participants will be followed for approximately 90-day or to outcome (e.g., withdrawal, death), whichever occurs first.
Angiographic revascularization of the occluded target vessel immediately post- procedure as defined by modified Thrombolysis in Cerebral Infarction (mTICI) 2b or higher Angiographic revascularization of the occluded target vessel immediately post- procedure as defined by mTICI 2c or higher * Angiographic revascularization of the occluded target vessel after the first pass as defined by mTICI 2b or higher * Angiographic revascularization of the occluded target vessel after the first pass as defined by mTICI 2c or higher
次要结局
未报告次要终点