Collects real-world data on the Penumbra System in acute ischemic stroke
Gathers safety and performance data on a device used to treat stroke.
Plain-language title generated from the registry record
Registry title: Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).
Key facts
- Where
- Kelowna and Toronto, CanadaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07107022, who can take part
Where in Canada
- Kelowna General HospitalKelowna, CanadaTaking people
- Toronto Western HospitalToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Penumbra Inc.
- Trial code
- NCT07107022
- Record updated
- 20 October 2026
- Original description
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)Read full original descriptionShow less
i-RISE: International Acute Ischemic Stroke Study With the Penumbra System®
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)
Inclusion: 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: 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; 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.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; epidemiological studies are eligible.