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

Study Overview
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Brief Summary
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The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

Detailed Description
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Registry Objective: The primary objective of this registry is to collect real-world performance and safety 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.

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

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Device: Penumbra System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with acute ischemic stroke secondary to LVO<br> | Device: Penumbra System<br>* Penumbra System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mTICI Score | Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score 2b or higher. mTICI scale ranges 0 to 3 higher values represent better outcomes. | Post Procedure | 
| Functional Subject Outcome | Functional subject outcome at 90 days post-procedure as defined by a modified Rankin Scale (mRS) 0-2. mRS scale ranges 0 to 6 higher values represent a worse outcome. | 90 days post | 
| All-cause mortality at 90 days | All-cause mortality at 90 days | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device and procedure related Serious Adverse Events (SAEs) |  | Within 24 hours of procedure | 
| Occurrence of embolization in previously uninvolved (or new) territories (ENT) | Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure | During Procedure | 
| Occurrence of symptomatic intracranial hemorrhages (sICH) |  | 24 Hours Post Procedure | 
| Time to Revascularization |  | During Procedure | 
| Length of hospital stay |  | Through discharge, up to study completion at approximately 90 days | 
| Discharge Facility |  | Through discharge, up to study completion at approximately 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Large Vessel Occlusion, Acute Ischemic Stroke, Mechanical Thrombectomy, Penumbra System, 3D Revascularization