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NCT Number: NCT07107022

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

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)

Recruiting

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Key information

Conditions

Acute Ischemic Stroke (AIS) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Penumbra System ®

Device

Neurovacular Mechanical Thrombectomy with the Penumbra System®

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Celina Wang

CONTACT

[email protected]

+49 175 1938 209

Egon Wülfert

CONTACT

[email protected]

+32 470 032 028

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Official study title

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

Acronym: i-RISE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 6, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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