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Recruiting NCT07107022

Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).

Conditions: Acute Ischemic Stroke (AIS)

Sponsor: Penumbra Inc.

trial.available_in: БГ
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)
Description
Post-market, real-world, prospective, single-arm, multi-center study that will enroll up to 200 participants at up to 15 sites globally
Who can participate
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
Locations 4
Australia (1)
Sir Charles Gairdner Hospital
Nedlands , Western Australia
Timothy Neurological Intervention & Imaging Service of WA (NIISwa)
France (1)
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux
Radiologie/Neuro-imagerie diagnostique et thérapeutique
Germany (1)
Knappschaft Kliniken Vest Recklinghausen
Recklinghausen , Westphalia
Switzerland (1)
Universitätsspital Basel
Basel , Basel-Landschaft
Diagnostic and interventional neuroradiology Secretary
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
01.11.2025
Completion date
01.12.2027
Registry ID
NCT07107022
Source
anzctr
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