About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients presenting with acute ischemic stroke (AIS) who are eligible for aspiration based mechanical thrombectomy
Trial design
Cohort
Prospective
Treatments tested in this trial
Penumbra System ®
DeviceNeurovacular Mechanical Thrombectomy with the Penumbra System®
Treatment groups
Trial outcomes
Primary outcomes
Outcomes:
Angiographic revascularization of the occluded target vessel immediately post- procedure as defined by modified Thrombolysis in Cerebral Infarction (mTICI) 2b or higher Angiographic revascularization of the occluded target vessel immediately post- procedure as defined by mTICI 2c or higher * Angiographic revascularization of the occluded target vessel after the first pass as defined by mTICI 2b or higher * Angiographic revascularization of the occluded target vessel after the first pass as defined by mTICI 2c or higher
Sponsors and contacts
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