Real-world performance and safety of the Penumbra System in acute ischemic stroke
i-RISE: International Acute Ischemic Stroke Study With the Penumbra System®
This project will test how the Penumbra mechanical thrombectomy system performs and how safe it is in adults aged 18–75 who have acute ischemic stroke and are eligible for clot removal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Penumbra Inc. Industry-sponsored |
| Locations | 10 sites (Nedlands, Western Australia and 9 other locations) |
| Trial ID | NCT07107022 on ClinicalTrials.gov |
What this trial studies
This is a post-market, prospective, single-arm, multi-center observational study enrolling up to 200 participants at as many as 15 global sites to collect real-world performance and safety data on the Penumbra System used as frontline mechanical thrombectomy. Eligible adults (18–75 years) will have pre-stroke mRS 0–1 and be candidates for endovascular clot removal, with baseline imaging criteria (ASPECTS >6 for anterior circulation). Data will capture procedural outcomes, device performance metrics, adverse events, and clinical status through 90 days of follow-up. No randomized comparator is used; all procedures use the commercially available Penumbra devices in routine clinical practice.
Who should consider this trial
Good fit: Adults aged 18–75 with acute ischemic stroke who have pre-stroke mRS 0–1, meet imaging criteria (ASPECTS >6 for anterior circulation), and are eligible for frontline mechanical thrombectomy with the Penumbra System are the ideal candidates.
Not a fit: Patients with low ASPECTS (≤6), significant pre-existing disability, comorbidities limiting 90-day survival or follow-up, or those not eligible for mechanical thrombectomy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could strengthen real-world evidence that the Penumbra System is safe and effective in routine clinical use, helping clinicians and hospitals make informed treatment choices.
How similar studies have performed: Mechanical thrombectomy has proven benefit in randomized trials and multiple device registries, and prior post-market and registry data for Penumbra devices exist, so this study builds on an established treatment and device experience.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nedlands, Western Australia and 9 other locations
- Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia (Recruiting)
- CHU de Bordeaux - Hôpital Pellegrin — Bordeaux, France (Recruiting)
- CHU de Brest - Hôpital de la Cavale Blanche — Brest, France (Recruiting)
- Hôpital Pierre-Paul Riquet — Toulouse, France (Recruiting)
- TUM Klinikum rechts der Isar — München, Bavaria, Germany (Recruiting)
- Knappschaft Kliniken Vest Recklinghausen — Recklinghausen, Westphalia, Germany (Recruiting)
- Universitätsklinikum Augsburg — Augsburg, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck — Lübeck, Germany (Recruiting)
- Universitätsspital Basel — Basel, Basel-Landschaft, Switzerland (Recruiting)
- Inselspital Universitätsklinik für Neurologie — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Marios Nikos Psychogios, Prof MD — University Hospital of Basel, Switzerland
- Study coordinator: Celina Wang
- Email: cwang1@penumbrainc.com
- Phone: +49 175 1938 209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.