LOTUS: Global Acute Stroke Study Utilizing Penumbra System

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