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

Recruitingn/aAges 18 Years - 80 YearsAllPenumbra Inc.
NCT07107022 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
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
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What it tests

  • Penumbra System ®
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Where

12 sites
Sir Charles Gairdner Hospital
Nedlands, Australia
Kelowna General Hospital
Kelowna, Canada
Toronto Western Hospital
Toronto, Canada
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
CHU de Brest - Hôpital de la Cavale Blanche
Brest, France
Hôpital Pierre-Paul Riquet
Toulouse, France
TUM Klinikum rechts der Isar
München, Germany
Knappschaft Kliniken Vest Recklinghausen
Recklinghausen, Germany

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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