THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing

Inclusion criteria

• Patient age 18 - 80 years
• Treatment within 8 hours of symptom onset
• Pre-stroke mRS 0-2
• Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion in the internal carotid, middle cerebral (M1 or M2), basilar, or vertebral artery
• If patient is eligible for thrombolytic therapy, it was administered as soon as possible, and no later than 3 hours from stroke symptom onset
• Planned frontline treatment with Penumbra System including Thunderbolt modulated aspiration
• Informed consent obtained per Institution Review Board/Ethics Committee requirements

Exclusion criteria

• Stenosis, excessive tortuosity, or any occlusion in a proximal vessel requiring treatment or preventing access to the thrombus
• Alberta Stroke Program Early CT Score (ASPECTS) ≤6 or core infarct volume >50 mL on MRI or CT-based imaging (for anterior circulation strokes)
• Pregnant patient
• Life expectancy < 90 days due to comorbidities
• Current participation in an interventional drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies
• Other medical, behavioral, or psychological conditions that in the opinion of the Investigator could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study