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
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07107022