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

NCT07107022

RecruitingN/A

Sponsor: Penumbra Inc.

Conditions: Acute Ischemic Stroke (AIS)

Interventions: Penumbra System ®

Countries: Australia, France, Germany, Switzerland

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)

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (10)
  • Nedlands, Western Australia, Australia
  • Bordeaux, France
  • Brest, France
  • Toulouse, France
  • München, Bavaria, Germany
  • Recklinghausen, Westphalia, Germany
  • Augsburg, Germany
  • Lübeck, Germany
  • Basel, Basel-Landschaft, Switzerland
  • Bern, Switzerland