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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorPenumbra Inc.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Penumbra System ®

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators