Business decision to focus on other studies. No safety concern

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).

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

Patients experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System