Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).

i-RISE: International Acute Ischemic Stroke Study With the Penumbra System®

The primary objective of this study is to collect real-world performance and safety data on the Penumbra System in a patient population with acute ischemic stroke (AIS)

Post-market, real-world, prospective, single-arm, multi-center study that will enroll up to 200 participants at up to 15 sites globally

Inclusion Criteria:

• I.1. Patient age 18-80 years
• I.2. Pre-stroke mRS 0-1
• I.3. Patients experiencing acute ischemic stroke who are eligible for mechanical thrombectomy using the Penumbra System
• I.4. Frontline treatment with Penumbra System
• I.5. Signed informed consent per Institution Review Board/Ethics Committee

Exclusion Criteria:

• E.1. Alberta Stroke Program Early CT Score (ASPECTS) ≤6 (for anterior circulation strokes)
• E.2. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
• E.3. Currently participating in an investigational (drug, device, etc.) clinical trial that will influence the endovascular procedure or acute treatment of the patient. Patients in secondary prevention, observational, natural history, and/or
• epidemiological studies are eligible.
• E.4. 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