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

NCT ID: NCT07107022

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-01

Study Completion Date

2027-12-31

Brief Summary

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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)

Detailed Description

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

Conditions

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Acute Ischemic Stroke (AIS)

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with acute ischemic stroke (AIS)

Device: Penumbra System®

Penumbra System ®

Intervention Type DEVICE

Neurovacular Mechanical Thrombectomy with the Penumbra System®

Interventions

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Penumbra System ®

Neurovacular Mechanical Thrombectomy with the Penumbra System®

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Penumbra Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marios Nikos Psychogios, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Basel, Switzerland

Locations

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Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status RECRUITING

Universitätsspital Basel

Basel, Basel-Landschaft, Switzerland

Site Status RECRUITING

Countries

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Australia Switzerland

Central Contacts

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Celina Wang

Role: CONTACT

Phone: 0049 175 1938 209

Email: [email protected]

Jennifer Jelf

Role: CONTACT

Phone: +1 949 910 5357

Email: [email protected]

Facility Contacts

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Timothy Phillips, MD

Role: primary

Marios Nikos Psychogios, Prof. Dr. med.

Role: primary

Other Identifiers

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CLP 30324

Identifier Type: -

Identifier Source: org_study_id