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

NCT07107022 | Recruiting FDA Device

• 1 other identifier: CLP 30324
• Study Type: observational
• Target: 200
• Locations: 4 countries
• Sites: 10

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Patients with acute ischemic stroke (AIS)

Device: Penumbra System®

Device: Penumbra System ®

Interventions

Penumbra System ® DEVICE

Neurovacular Mechanical Thrombectomy with the Penumbra System®

Patients with acute ischemic stroke (AIS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (10)

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

RECRUITING

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33000, France

RECRUITING

CHU de Brest - Hôpital de la Cavale Blanche

Brest, 29200, France

RECRUITING

Hôpital Pierre-Paul Riquet

Toulouse, 31300, France

RECRUITING

TUM Klinikum rechts der Isar

München, Bavaria, 81675, Germany

RECRUITING

Knappschaft Kliniken Vest Recklinghausen

Recklinghausen, Westphalia, 45657, Germany

RECRUITING

Universitätsklinikum Augsburg

Augsburg, 86156, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck

Lübeck, 23538, Germany

RECRUITING

Universitätsspital Basel

Basel, Basel-Landschaft, 4031, Switzerland

RECRUITING

Inselspital Universitätsklinik für Neurologie

Bern, 3006, Switzerland

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marios Nikos Psychogios, Prof MD

  University Hospital of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celina Wang

CONTACT

+49 175 1938 209; cwang1@penumbrainc.com

Jennifer Jelf

CONTACT

+1 949 910 5357; jjelf@penumbrainc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); DE (4); CH (2); AU (1)