COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device

Registry Objective: The primary objective of this registry is to collect data on Penumbra
System including the 3D Revascularization Device in a patient population with acute ischemic
stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

Registry Design: This will be a prospective, single-arm, multi-center observational registry
and will include patients that present with either anterior or posterior LVO who are eligible
for mechanical thrombectomy using the Penumbra System.

Registry Duration: Subjects will be in the registry for approximately 90 days from enrollment
to last follow-up.

Data Management: Electronic Case Report Forms (eCRFs) will be used at all investigational
sites. All registry data will be entered into commercially available web-based electronic
data capture system (EDC). Data entry will be performed by the study site personnel.
Automated data quality checks will display warnings for invalid data. Additionally, manual
review of data listings may be used to identify data discrepancies or inconsistencies.

Inclusion Criteria:

- Patient age ≥ 18

- Pre-stroke mRS 0-1

- 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 Penumbra System

- Signed informed consent per Institution Review Board/Ethics Committee

Exclusion Criteria:

- Any comorbid disease or condition expected to compromise survival or ability to
complete follow-up assessments through 90 days.

- 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.