Real-world performance and safety of the Penumbra System in acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a post-market, prospective, single-arm, multi-center observational study enrolling up to 200 participants at as many as 15 global sites to collect real-world performance and safety data on the Penumbra System used as frontline mechanical thrombectomy. Eligible adults (18–75 years) will have pre-stroke mRS 0–1 and be candidates for endovascular clot removal, with baseline imaging criteria (ASPECTS >6 for anterior circulation). Data will capture procedural outcomes, device performance metrics, adverse events, and clinical status through 90 days of follow-up. No randomized comparator is used; all procedures use the commercially available Penumbra devices in routine clinical practice.

Why it matters

Who can join: the full rules

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

Where it's running

• Sir Charles Gairdner Hospital
  Nedlands, Western Australia, Australia Recruiting
• Kelowna General Hospital
  Kelowna, British Columbia, Canada Recruiting
• Toronto Western Hospital
  Toronto, Ontario, Canada Recruiting
• CHU de Bordeaux - Hôpital Pellegrin
  Bordeaux, France Recruiting
• CHU de Brest - Hôpital de la Cavale Blanche
  Brest, France Recruiting
• Hôpital Pierre-Paul Riquet
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Marios Nikos Psychogios, Prof MD — University Hospital of Basel, Switzerland
• Study coordinator: Celina Wang
• Email: cwang1@penumbrainc.com
• Phone: +49 175 1938 209

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.