Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT07107022

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

Led by Penumbra Inc. · Updated on 2026-04-27

200

Participants Needed

10

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient age 18 to 75 years
  • Pre-stroke modified Rankin Scale (mRS) score of 0 or 1
  • Patients experiencing acute ischemic stroke eligible for mechanical thrombectomy with the Penumbra System
  • Frontline treatment planned using the Penumbra System
  • Signed informed consent as per Institutional Review Board/Ethics Committee requirements
Not Eligible

You will not qualify if you...

  • Alberta Stroke Program Early CT Score (ASPECTS) of 6 or less for anterior circulation strokes
  • Any comorbid disease or condition expected to compromise survival or ability to complete 90-day follow-up assessments
  • Currently participating in an investigational clinical trial influencing endovascular or acute stroke treatment, except secondary prevention, observational, natural history, or epidemiological studies
  • Medical, behavioral, or psychological conditions that could limit participation, compliance with follow-up, or impact scientific integrity as judged by the Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

2

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, France, 33000

Actively Recruiting

3

CHU de Brest - Hôpital de la Cavale Blanche

Brest, France, 29200

Actively Recruiting

4

Hôpital Pierre-Paul Riquet

Toulouse, France, 31300

Actively Recruiting

5

TUM Klinikum rechts der Isar

München, Bavaria, Germany, 81675

Actively Recruiting

6

Knappschaft Kliniken Vest Recklinghausen

Recklinghausen, Westphalia, Germany, 45657

Actively Recruiting

7

Universitätsklinikum Augsburg

Augsburg, Germany, 86156

Actively Recruiting

8

Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck

Lübeck, Germany, 23538

Actively Recruiting

9

Universitätsspital Basel

Basel, Basel-Landschaft, Switzerland, 4031

Actively Recruiting

10

Inselspital Universitätsklinik für Neurologie

Bern, Switzerland, 3006

Actively Recruiting

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Research Team

C

Celina Wang

CONTACT

J

Jennifer Jelf

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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