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

NCT07107022 · tracked via the Priya Life Science Germany tracker

Sponsor

Penumbra Inc

Phase

Observational

Started

2025-11-01

Last updated

2026-07-27

Condition(s) studied

Acute Ischemic Stroke (AIS)

Investigational drug(s) / intervention(s)

Penumbra System ®

Penumbra System ®: Neurovacular Mechanical Thrombectomy with the Penumbra System®

Study 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)

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

Outcomes: — 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

Trial sites (10)

Facility	City	Region	Status
Sir Charles Gairdner Hospital	Nedlands	Western Australia	Recruiting
CHU de Bordeaux - Hôpital Pellegrin	Bordeaux	France	Recruiting
CHU de Brest - Hôpital de la Cavale Blanche	Brest	France	Recruiting
Hôpital Pierre-Paul Riquet	Toulouse	France	Recruiting
TUM Klinikum rechts der Isar	München	Bavaria	Recruiting
Knappschaft Kliniken Vest Recklinghausen	Recklinghausen	Westphalia	Recruiting
Universitätsklinikum Augsburg	Augsburg	Germany	Recruiting
Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck	Lübeck	Germany	Recruiting
Universitätsspital Basel	Basel	Basel-Landschaft	Recruiting
Inselspital Universitätsklinik für Neurologie	Bern	Switzerland	Recruiting

More Penumbra Inc. trials in Germany

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System Recruiting

A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07107022 on ClinicalTrials.gov ↗ ← All trials in Germany