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New stroke device aims to quickly clear blocked arteries

NCT ID NCT07107022

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    10 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU de Bordeaux - Hôpital Pellegrin

    RECRUITING

    Bordeaux, 33000, France

  • CHU de Brest - Hôpital de la Cavale Blanche

    RECRUITING

    Brest, 29200, France

  • Hôpital Pierre-Paul Riquet

    RECRUITING

    Toulouse, 31300, France

  • Inselspital Universitätsklinik für Neurologie

    RECRUITING

    Bern, 3006, Switzerland

  • Knappschaft Kliniken Vest Recklinghausen

    RECRUITING

    Recklinghausen, Westphalia, 45657, Germany

  • Sir Charles Gairdner Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • TUM Klinikum rechts der Isar

    RECRUITING

    München, Bavaria, 81675, Germany

  • Universitätsklinikum Augsburg

    RECRUITING

    Augsburg, 86156, Germany

  • Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck

    RECRUITING

    Lübeck, 23538, Germany

  • Universitätsspital Basel

    RECRUITING

    Basel, Basel-Landschaft, 4031, Switzerland

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