NCT04157270终止不适用
LOTUS: Global Acute Stroke Study Utilizing Penumbra System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- mTICI Score
研究概览
简要总结
The primary objective of this study is to demonstrate safety and effectiveness of the Penumbra System in a population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥ 18 and ≤ 85
- •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 aspiration utilizing Penumbra System
- •Present with symptoms consistent with an acute ischemic stroke within 8 hours of stroke symptom onset
- •National Institute of Health Stroke Scale (NIHSS) ≥ 6
- •Signed informed consent per Institution Review Board/Ethics Committee
- •CT ASPECT score from 6 to 10 (≥ 6) or according to MR DWI ASPECT score from 5 to 10 (≥ 5)
- •Pre-stroke mRS 0-1
排除标准
- •Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
- •Associated myocardial infarction or severe infection (endocarditis or sepsis)
- •Laboratory evidence of coagulation abnormalities, with an International Normalized Ratio (INR) or > 3.0 or platelets count < 40 x 10^9/L or PTT/APTT > 50 sec
- •Uncontrolled hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg)
- •Baseline glucose < 2.7 or > 22.2 mmol/L
- •Seizure at the onset of stroke
- •Time of stroke symptom onset unknown
- •Females who are pregnant
- •Known serious sensitivity to radiographic contrast media that cannot be pre-treated
- •Renal failure as defined by serum creatinine > 3.0mg/dl (264 µmol/L)
- •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
- •CT/MRI evidence of the following conditions at screening: significant mass effect with midline shift, evidence of intracranial hemorrhage (ICH), aneurysm, or arteriovenous malformation (AVM), or intracranial tumor
- •. Angiographic evidence of preexisting arterial injury, such as carotid dissection, complete cervical carotid occlusion, or vasculitis.
- •Angiographic evidence of occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories
- •Excessive arterial tortuosity that would prevent the device from reaching the target vessel
结局指标
主要结局
mTICI Score
时间窗: Immediate Post Procedure
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score of 2b or higher. mTICI scale ranges from 0 to 3 with higher values representing better outcomes.
Functional Subject Outcome
时间窗: 90 days post
Good functional subject outcome at 90 days post-procedure as defined by modified Rankin Scale (mRS) 0-2. mRS scale from from 0 to 6 with higher values representing a worse outcome.
All-cause mortality at 90 days
时间窗: 90 days
All-cause mortality at 90 days
次要结局
- Complete Revascularization(Immediate Post Procedure)
- Safety: Device and procedure related SAE(Up to 30 days Post Procedure)
- Safety: Occurrence of Symptomatic intracranial hemorrhage(Up to 24 Hours Post Procedure)
- Stroke Onset to Revascularization(Immediate Post Procedure)
- Safety: Occurrence of ENT(Immediate Post Procedure)
- Procedural Time(Immediate Post Procedure)
- Type of Discharge Facility(Up to 90 days Post Procedure)
- Length of index hospital stay(Up to 90 days Post Procedure)
研究者
研究点 (2)
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