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RECRUITINGOBSERVATIONAL

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®

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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)

Who May Be Eligible (Plain English)

Who May Qualify: - I.1. Patient age 18-75 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 willing to sign a consent form per Institution Review Board/Ethics Committee Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * I.1. Patient age 18-75 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

Treatments Being Tested

DEVICE

Penumbra System ®

Neurovacular Mechanical Thrombectomy with the Penumbra System®

Locations (9)

Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
CHU de Brest - Hôpital de la Cavale Blanche
Brest, France
Hôpital Pierre-Paul Riquet
Toulouse, France
Knappschaft Kliniken Vest Recklinghausen
Recklinghausen, Westphalia, Germany
Universitätsklinikum Augsburg
Augsburg, Germany
Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck
Lübeck, Germany
Universitätsspital Basel
Basel, Basel-Landschaft, Switzerland
Inselspital Universitätsklinik für Neurologie
Bern, Switzerland