Acute Ischemic Stroke (AIS)i-RISENCT07107022
Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).
An observational study of Acute Ischemic Stroke (AIS), run by Penumbra Inc. at 12 sites in 5 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke (AIS)
- What is being tested?
- Penumbra System ®
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 1 Nov 2025to Apr 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with acute ischemic stroke (AIS) who are eligible for aspiration based mechanical thrombectomy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 5 countries
Germany4 sites, 4 recruiting
- Recruiting
Universitätsklinikum Augsburg
Augsburg, 86156
Lehrstuhl für Diagnostische/Interventionelle Neuroradiologie, +49 821 400 2468, neuroradiologie@uk-augsburg.de
Ansgar Berlis, Prof MD
- Recruiting
Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck
Lübeck, 23538
Neuroradiology Institute, +49 451 500-10735, international@uksh.de
Peter Schramm, Prof. MD
- Recruiting
TUM Klinikum rechts der Isar
München, Bavaria, 81675
Institut für Neuroradiologie, +49 89 41404651, sigrid.matussek@mri.tum.de
Tobias Boeckh-Behrens, MD
- Recruiting
Knappschaft Kliniken Vest Recklinghausen
Recklinghausen, Westphalia, 45657
Knappschaft Kliniken Radiologie Imvest, +492361-56-83890, Christian.Loehr@knappschaft-kliniken.de
Christian Loehr, MD
France3 sites, 3 recruiting
- Recruiting
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
Radiologie/Neuro-imagerie diagnostique et thérapeutique, +33 (0)540 451 200, omer.eker@chu-bordeaux.fr
Omer Eker, Prof MD
- Recruiting
CHU de Brest - Hôpital de la Cavale Blanche
Brest, 29200
Neuro-radiologie interventionnelle, +33 2 98 34 74 87, jean-christophe.gentric@chu-brest.fr
Jean-Christophe Gentric, Prof MD
- Recruiting
Hôpital Pierre-Paul Riquet
Toulouse, 31300
Neuroradiologie diagnostique et thérapeutique, +33 5 61 77 23 39, cognard.c@chu-toulouse.fr
Christophe Cognard, Prof MD
Canada2 sites, 2 recruiting
- Recruiting
Kelowna General Hospital
Kelowna, British Columbia, V1Y 1T2
Helena Neudorf, PhD, 2502584331, helena.neudorf@interiorhealth.ca
Gage Watson, MD
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Brian Coman, MSc, 416 603 5871, briar.coman@uhn.ca
David Volders, MD
Switzerland2 sites, 2 recruiting
- Recruiting
Universitätsspital Basel
Basel, Basel-Landschaft, 4031
Diagnostic and interventional neuroradiology Secretary, +41 61 328 63 70, yasmineceline.wick@usb.ch
Marios Nikos Psychogios, Prof MD
- Recruiting
Inselspital Universitätsklinik für Neurologie
Bern, 3006
Universitätsklinik für Neurologie Inselspital, +41 31 632 70 00, neurozentrum@insel.ch
Tomas Dobrocky, MD
Australia1 site, 1 recruiting
- Recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Timothy Neurological Intervention & Imaging Service of WA (NIISwa), +61 8 6457 4455, SCGH.RadiologyReception@health.wa.gov.au
Thimothy Phillips, MD
About this study
Official title: 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)
Read the detailed description
Post-market, real-world, prospective, single-arm, multi-center study that will enroll up to 200 participants at up to 15 sites globally
- Conditions
- Acute Ischemic Stroke (AIS)
- Being tested
- Penumbra System ®
- Keywords
- Penumbra System, Thrombectomy, Penumbra ENGINE®, mechanical thrombectomy, Neuro Thrombectomy, Neurovascular Catheters
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penumbra System ®Device
Neurovacular Mechanical Thrombectomy with the Penumbra System®
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute ischemic stroke (AIS) | Device: Penumbra System® Receives: Device: Penumbra System ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes:
Angiographic revascularization of the occluded target vessel immediately post- procedure as defined by modified Thrombolysis in Cerebral Infarction (mTICI) 2b or higher Angiographic revascularization of the occluded target vessel immediately post- procedure as defined by mTICI 2c or higher
- Angiographic revascularization of the occluded target vessel after the first pass as defined by mTICI 2b or higher
- Angiographic revascularization of the occluded target vessel after the first pass as defined by mTICI 2c or higher
Measured: It is anticipated this study will take approximately 2 years. All participants will be followed for approximately 90-day or to outcome (e.g., withdrawal, death), whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Nov 2025
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke (AIS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marios Nikos Psychogios, Prof MD, Principal investigator, University Hospital of Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107022
- Sponsor's protocol ID
- CLP 30324
- Acronym
- i-RISE
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No