Acute Ischemic Stroke (AIS)
Conditions
Keywords
Penumbra System, Thrombectomy, Penumbra ENGINE®, mechanical thrombectomy, Neuro Thrombectomy, Neurovascular Catheters
Brief 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)
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
DEVICEPenumbra System ®
Neurovacular Mechanical Thrombectomy with the Penumbra System®
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcomes: | 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 |
Countries
Australia, France, Germany, Switzerland
Contacts
CONTACTCelina Wang
CONTACTEgon Wülfert
PRINCIPAL_INVESTIGATORMarios Nikos Psychogios, Prof MD
University Hospital of Basel, Switzerland
Outcome results
None listed