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

July 24, 2026 updated by: Penumbra Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Sir Charles Gairdner Hospital
        • Principal Investigator:
          • Thimothy Phillips, MD
        • Contact:
  • France
      • Bordeaux, France, 33000
        • Recruiting
        • CHU de Bordeaux - Hôpital Pellegrin
        • Contact:
        • Principal Investigator:
          • Omer Eker, Prof MD
      • Brest, France, 29200
        • Recruiting
        • CHU de Brest - Hopital de la Cavale Blanche
        • Contact:
        • Principal Investigator:
          • Jean-Christophe Gentric, Prof MD
      • Toulouse, France, 31300
        • Recruiting
        • Hôpital Pierre-Paul Riquet
        • Contact:
        • Principal Investigator:
          • Christophe Cognard, Prof MD
  • Germany
      • Augsburg, Germany, 86156
        • Recruiting
        • Universitätsklinikum Augsburg
        • Contact:
        • Principal Investigator:
          • Ansgar Berlis, Prof MD
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck
        • Contact:
        • Principal Investigator:
          • Peter Schramm, Prof. MD
    • Bavaria
      • München, Bavaria, Germany, 81675
        • Recruiting
        • TUM Klinikum rechts der Isar
        • Principal Investigator:
          • Tobias Boeckh-Behrens, MD
        • Contact:
    • Westphalia
      • Recklinghausen, Westphalia, Germany, 45657
        • Recruiting
        • Knappschaft Kliniken Vest Recklinghausen
        • Contact:
        • 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
        • Universitätsspital Basel
        • Contact:
        • Principal Investigator:
          • Marios Nikos Psychogios, Prof MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 18-80 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penumbra Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marios Nikos Psychogios, Prof MD, University Hospital of Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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