LOTUS: Global Acute Stroke Study Utilizing Penumbra System
关键词
抽象
日期
| 最后验证: | 03/31/2020 |
| 首次提交: | 10/03/2019 |
| 提交的预估入学人数: | 11/04/2019 |
| 首次发布: | 11/07/2019 |
| 上次提交的更新: | 04/29/2020 |
| 最近更新发布: | 05/03/2020 |
| 实际学习开始日期: | 01/11/2020 |
| 预计主要完成日期: | 12/31/2021 |
| 预计完成日期: | 07/31/2022 |
状况或疾病
干预/治疗
Device: Patients with acute ischemic stroke
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Patients with acute ischemic stroke Patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO) | Device: Patients with acute ischemic stroke Penumbra System |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. mTICI Score [Immediate Post Procedure]
2. Functional Subject Outcome [90 days post]
3. All-cause mortality at 90 days [90 days]
次要成果指标
1. Safety: Device and procedure related SAE [Up to 30 days Post Procedure]
2. Safety: Occurrence of ENT [Immediate Post Procedure]
3. Safety: Occurrence of Symptomatic intracranial hemorrhage [Up to 24 Hours Post Procedure]
4. Procedural Time [Immediate Post Procedure]
5. Stroke Onset to Revascularization [Immediate Post Procedure]
6. Complete Revascularization [Immediate Post Procedure]
7. Length of index hospital stay [Up to 90 days Post Procedure]
8. Type of Discharge Facility [Up to 90 days Post Procedure]
