Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).
- Conditions
- Acute Ischemic Stroke (AIS)
- Registration Number
- NCT07107022
- Lead Sponsor
- Penumbra Inc.
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method