LOTUS: Global Acute Stroke Study Utilizing Penumbra System

Study Overview
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Brief Summary
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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).

Official Title
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LOTUS: Global Acute Stroke Study Utilizing Penumbra System

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Device: Penumbra System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with acute ischemic stroke<br>Patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO) | Device: Penumbra System<br>* Penumbra System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mTICI Score | 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. | Immediate Post Procedure | 
| Functional Subject Outcome | 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. | 90 days post | 
| All-cause mortality at 90 days | All-cause mortality at 90 days | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Device and procedure related SAE | Incidence of device and procedure related Serious Adverse Events (SAEs) | Up to 30 days Post Procedure | 
| Safety: Occurrence of ENT | Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure | Immediate Post Procedure | 
| Safety: Occurrence of Symptomatic intracranial hemorrhage | Occurrence of symptomatic hemorrhages (sICH) at 24 hours | Up to 24 Hours Post Procedure | 
| Procedural Time | Time from the arterial puncture to revascularization defined by mTICI 2b or greater | Immediate Post Procedure | 
| Stroke Onset to Revascularization | Time from stroke onset to revascularization defined by mTICI 2b or greater | Immediate Post Procedure | 
| Complete Revascularization | Complete revascularization, defined as mTICI 2c and 3 | Immediate Post Procedure | 
| Length of index hospital stay |  | Up to 90 days Post Procedure | 
| Type of Discharge Facility |  | Up to 90 days Post Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Large Vessel Occlusion, LVO, Mechanical Thrombectomy, Penumbra System