NCT07107022Recruiting
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®
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 1 Nov 2025
- Primary completion date
- Jan 2028
- Lead sponsor
- Penumbra Inc.
- Diseases
- Stroke
- NCT number
- NCT07107022
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Nov 2025 to the primary completion date, Jan 2028
- 12 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- epidemiological studies are eligible.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Charles Gairdner Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Kelowna General Hospital Coordinator of this site? Confirm its status | Kelowna | Canada | Recruiting |
| Toronto Western Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Universitätsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Inselspital Universitätsklinik für Neurologie Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Universitätsklinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Recruiting |
| Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
| TUM Klinikum rechts der Isar Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Knappschaft Kliniken Vest Recklinghausen Coordinator of this site? Confirm its status | Recklinghausen | Germany | Recruiting |
| CHU de Bordeaux - Hôpital Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU de Brest - Hopital de la Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Hopital Pierre Paul Riquet Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.