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Набира участници NCT07107022

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

Заболявания: Acute Ischemic Stroke (AIS)

Спонсор: Penumbra Inc.

Налично на: БГ
Обобщение
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)
Описание
Post-market, real-world, prospective, single-arm, multi-center study that will enroll up to 200 participants at up to 15 sites globally
Кой може да участва
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
Места на провеждане 4
Австралия (1)
Sir Charles Gairdner Hospital
Nedlands , Western Australia
Timothy Neurological Intervention & Imaging Service of WA (NIISwa)
Франция (1)
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux
Radiologie/Neuro-imagerie diagnostique et thérapeutique
Германия (1)
Knappschaft Kliniken Vest Recklinghausen
Recklinghausen , Westphalia
Швейцария (1)
Universitätsspital Basel
Basel , Basel-Landschaft
Diagnostic and interventional neuroradiology Secretary
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
01.11.2025
Крайна дата
01.12.2027
Регистрационен номер
NCT07107022
Източник
anzctr
Запитване за медицински туризъм

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