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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- i-RISE: International Acute Ischemic Stroke Study With the Penumbra System®
- ClinicalTrials.gov ID
- NCT07107022
- Acronym / sponsor ID
- i-RISE / CLP 30324
- Conditions
- Acute Ischemic Stroke (AIS)
- Keywords
- Penumbra System, Thrombectomy, Penumbra ENGINE®, mechanical thrombectomy, Neuro Thrombectomy, Neurovascular Catheters
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute ischemic stroke (AIS) | – | Device: Penumbra System ®Device: Penumbra System® |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with acute ischemic stroke (AIS) who are eligible for aspiration based mechanical thrombectomy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penumbra System ®Neurovacular Mechanical Thrombectomy with the Penumbra System® | Device | Patients with acute ischemic stroke (AIS) |
Primary outcome
Outcomes:
Time frame: 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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 2/3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marios Nikos Psychogios, Prof MD principal investigator
University Hospital of Basel, Switzerland
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke (AIS), run by Penumbra Inc. at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, France, Canada, Switzerland, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celina Wang (+49 175 1938 209, cwang1@penumbrainc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcomes: (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.