Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Penumbra System ®.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke (AIS). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, France, Germany, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
i-RISE: International Acute Ischemic Stroke Study With the Penumbra System®
Overview
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
Interventions
- Device Penumbra System ®
Neurovacular Mechanical Thrombectomy with the Penumbra System®
Primary outcome measures
- 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.]
Eligibility criteria
Inclusion criteria
- 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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 4 centers
- TUM Klinikum rechts der Isar — München
- Knappschaft Kliniken Vest Recklinghausen — Recklinghausen
- Universitätsklinikum Augsburg — Augsburg
- Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck — Lübeck
France · 3 centers
- CHU de Bordeaux - Hôpital Pellegrin — Bordeaux
- CHU de Brest - Hôpital de la Cavale Blanche — Brest
- Hôpital Pierre-Paul Riquet — Toulouse
Switzerland · 2 centers
- Universitätsspital Basel — Basel
- Inselspital Universitätsklinik für Neurologie — Bern
Australia · 1 center
- Sir Charles Gairdner Hospital — Nedlands
Identifiers
NCT: NCT07107022 · CLP 30324