Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Ac… (NCT07107022) | Clinical Trial Compass
RecruitingNot Applicable
Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).
Australia, France, Germany200 participantsStarted 2025-11-01
Plain-language 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)
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
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
What they're measuring
1
Outcomes:
Timeframe: 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.