RecruitingNCT07107022

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®

Sponsor

Penumbra Inc.

Enrollment

200 participants

Start Date

Nov 1, 2025

Study Type

OBSERVATIONAL

Conditions

Acute Ischemic Stroke AIS

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria5

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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Interventions

DEVICEPenumbra System ®

Neurovacular Mechanical Thrombectomy with the Penumbra System®

Locations(10)

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

TUM Klinikum rechts der Isar

München, Bavaria, Germany

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

View Full Details on ClinicalTrials.gov

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NCT07107022

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