COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 42
- 主要终点
- Functional Subject Outcome
研究概览
简要总结
The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
详细描述
Registry Objective: The primary objective of this registry is to collect real-world performance and safety data on Penumbra System including the 3D Revascularization Device in a patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Registry Design: This will be a prospective, single-arm, multi-center observational registry and will include patients that present with either anterior or posterior LVO who are eligible for mechanical thrombectomy using the Penumbra System.
Registry Duration: Subjects will be in the registry for approximately 90 days from enrollment to last follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥ 18
- •Pre-stroke mRS 0-1
- •Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
- •Planned frontline treatment with Penumbra System
- •Signed informed consent per Institution Review Board/Ethics Committee
排除标准
- •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 confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
结局指标
主要结局
Functional Subject Outcome
时间窗: 90 days post
Functional subject outcome at 90 days post-procedure as defined by a modified Rankin Scale (mRS) 0-2. mRS scale ranges 0 to 6 higher values represent a worse outcome.
mTICI Score
时间窗: Post Procedure
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score 2b or higher. mTICI scale ranges 0 to 3 higher values represent better outcomes.
All-cause mortality at 90 days
时间窗: 90 days
All-cause mortality at 90 days
次要结局
- Incidence of device and procedure related Serious Adverse Events (SAEs)(Within 24 hours of procedure)
- Discharge Facility(Through discharge, up to study completion at approximately 90 days)
- Time to Revascularization(During Procedure)
- Occurrence of symptomatic intracranial hemorrhages (sICH)(24 Hours Post Procedure)
- Occurrence of embolization in previously uninvolved (or new) territories (ENT)(During Procedure)
- Length of hospital stay(Through discharge, up to study completion at approximately 90 days)