Recruiting

Penumbra System

Sponsor:

Penumbra Inc.

Code:

NCT07107022

Conditions

Acute Ischemic Stroke (AIS)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Penumbra System ®

Study Details

Brief summary:

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

Acute Ischemic Stroke (AIS)

Study ID

NCT07107022

Start date

Nov 1, 2025

Status verified date

Oct, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with acute ischemic stroke (AIS)

Device: Penumbra System®

Interventions

Penumbra System ®

Neurovacular Mechanical Thrombectomy with the Penumbra System®

Primary outcome measure

  • Outcomes: [ Time Frame: It is anticipated this study will take approximately 2 years. All participants will be followed for approximately 90-day or to outcome (e.g., withdrawal, death), whichever occurs first. ]

Central Contacts and Locations

Central contacts

Celina Wang

+49 175 1938 209cwang1@penumbrainc.com

Marie-Pierre Dewez

+32 499036232mpdewez@penumbrainc.com

Locations

Kelowna General Hospital

Recruiting

Kelowna, British Columbia, Canada, V1Y 1T2

Contacts

Helena Neudorf, PhD

2502584331helena.neudorf@interiorhealth.ca

Principal Investigator:

Gage Watson, MD

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Brian Coman, MSc

416 603 5871briar.coman@uhn.ca

Principal Investigator:

David Volders, MD

More Information

Sponsor

Penumbra Inc.

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • Penumbra System
  • Thrombectomy
  • Penumbra ENGINE®
  • mechanical thrombectomy
  • Neuro Thrombectomy
  • Neurovascular Catheters

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Penumbra Inc. on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.