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

i-RISE: International Acute Ischemic Stroke Study With the Penumbra System®

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)

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke (AIS)
• Intervention / Treatment: Device: Penumbra System ®

Detailed Description

Post-market, real-world, prospective, single-arm, multi-center study that will enroll up to 200 participants at up to 15 sites globally

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Celina Wang; Phone Number: +49 175 1938 209; Email: cwang1@penumbrainc.com
• Study Contact Backup: Name: Egon Wülfert; Phone Number: +32 470 032 028; Email: ewuelfert@penumbrainc.com

Study Locations

• Australia
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Sir Charles Gairdner Hospital
      • Principal Investigator: Thimothy Phillips, MD
      • Contact: Timothy Neurological Intervention & Imaging Service of WA (NIISwa); Phone Number: +61 8 6457 4455; Email: SCGH.RadiologyReception@health.wa.gov.au
• France
  • Bordeaux, France, 33000
    • Recruiting
    • CHU de Bordeaux - Hôpital Pellegrin
    • Contact: Radiologie/Neuro-imagerie diagnostique et thérapeutique; Phone Number: +33 (0)540 451 200; Email: omer.eker@chu-bordeaux.fr
    • Principal Investigator: Omer Eker, Prof MD
  • Brest, France, 29200
    • Recruiting
    • CHU de Brest - Hopital de la Cavale Blanche
    • Contact: Neuro-radiologie interventionnelle; Phone Number: +33 2 98 34 74 87; Email: jean-christophe.gentric@chu-brest.fr
    • Principal Investigator: Jean-Christophe Gentric, Prof MD
  • Toulouse, France, 31300
    • Recruiting
    • Hôpital Pierre-Paul Riquet
    • Contact: Neuroradiologie diagnostique et thérapeutique; Phone Number: +33 5 61 77 23 39; Email: cognard.c@chu-toulouse.fr
    • Principal Investigator: Christophe Cognard, Prof MD
• Germany
  • Augsburg, Germany, 86156
    • Recruiting
    • Universitätsklinikum Augsburg
    • Contact: Lehrstuhl für Diagnostische/Interventionelle Neuroradiologie; Phone Number: +49 821 400 2468; Email: neuroradiologie@uk-augsburg.de
    • Principal Investigator: Ansgar Berlis, Prof MD
  • Lübeck, Germany, 23538
    • Recruiting
    • Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck
    • Contact: Neuroradiology Institute; Phone Number: +49 451 500-10735; Email: international@uksh.de
    • Principal Investigator: Peter Schramm, Prof. MD
  • Bavaria
    • München, Bavaria, Germany, 81675
      • Recruiting
      • TUM Klinikum rechts der Isar
      • Principal Investigator: Tobias Boeckh-Behrens, MD
      • Contact: Institut für Neuroradiologie; Phone Number: +49 89 41404651; Email: sigrid.matussek@mri.tum.de
  • Westphalia
    • Recklinghausen, Westphalia, Germany, 45657
      • Recruiting
      • Knappschaft Kliniken Vest Recklinghausen
      • Contact: Knappschaft Kliniken Radiologie Imvest; Phone Number: +492361-56-83890; Email: Christian.Loehr@knappschaft-kliniken.de
      • Principal Investigator: Christian Loehr, MD
• Switzerland
  • Bern, Switzerland, 3006
    • Recruiting
    • Inselspital Universitätsklinik für Neurologie
    • Contact: Universitätsklinik für Neurologie Inselspital; Phone Number: +41 31 632 70 00; Email: neurozentrum@insel.ch
    • Principal Investigator: Tomas Dobrocky, MD
  • Basel-Landschaft
    • Basel, Basel-Landschaft, Switzerland, 4031
      • Recruiting
      • Universitatsspital Basel
      • Contact: Diagnostic and interventional neuroradiology Secretary; Phone Number: +41 61 328 63 70; Email: yasmineceline.wick@usb.ch
      • Principal Investigator: Marios Nikos Psychogios, Prof MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with acute ischemic stroke (AIS) who are eligible for aspiration based mechanical thrombectomy

Description

Inclusion Criteria:

• 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
• 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with acute ischemic stroke (AIS); Device: Penumbra System®	Device: Penumbra System ®; Neurovacular Mechanical Thrombectomy with the Penumbra System®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes:	Angiographic revascularization of the occluded target vessel immediately post- procedure as defined by modified Thrombolysis in Cerebral Infarction (mTICI) 2b or higher Angiographic revascularization of the occluded target vessel immediately post- procedure as defined by mTICI 2c or higher; Angiographic revascularization of the occluded target vessel after the first pass as defined by mTICI 2b or higher; Angiographic revascularization of the occluded target vessel after the first pass as defined by mTICI 2c or higher	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.

Collaborators and Investigators

• Sponsor: Penumbra Inc.
• Investigators: Principal Investigator: Marios Nikos Psychogios, Prof MD, University Hospital of Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: July 30, 2025
• First Submitted That Met QC Criteria: July 30, 2025
• First Posted (Actual): August 6, 2025

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Thrombectomy; mechanical thrombectomy; Penumbra System; Penumbra ENGINE®; Neuro Thrombectomy; Neurovascular Catheters
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: CLP 30324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes