New stroke device aims to quickly clear blocked arteries
NCT ID NCT07107022
First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times
Summary
This study is testing a medical device called the Penumbra System in 200 adults aged 18-75 who have had a severe stroke caused by a blocked artery. The device is used to remove the clot and restore blood flow to the brain. The main goal is to see how well and how safely the device opens the blocked vessel right after the procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients presenting with acute ischemic stroke (AIS) who are eligible for aspiration based mechanical thrombectomy
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Bordeaux - Hôpital Pellegrin
RECRUITINGBordeaux, 33000, France
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CHU de Brest - Hôpital de la Cavale Blanche
RECRUITINGBrest, 29200, France
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Hôpital Pierre-Paul Riquet
RECRUITINGToulouse, 31300, France
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Inselspital Universitätsklinik für Neurologie
RECRUITINGBern, 3006, Switzerland
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Knappschaft Kliniken Vest Recklinghausen
RECRUITINGRecklinghausen, Westphalia, 45657, Germany
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Sir Charles Gairdner Hospital
RECRUITINGNedlands, Western Australia, 6009, Australia
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TUM Klinikum rechts der Isar
RECRUITINGMünchen, Bavaria, 81675, Germany
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Universitätsklinikum Augsburg
RECRUITINGAugsburg, 86156, Germany
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Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck
RECRUITINGLübeck, 23538, Germany
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Universitätsspital Basel
RECRUITINGBasel, Basel-Landschaft, 4031, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a diabetes drug help the brain heal after a stroke?
- Stroke treatment upgrade: adding a Clot-Buster after clot removal may boost recovery
- Gene therapy particles aim to boost stroke recovery
- Balloon catheters may improve stroke clot removal
- Blood test may forecast stroke severity
- Could a single shot boost stroke recovery? new trial aims to find out