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New aspiration tubing aims to restore blood flow faster in major strokes

NCT ID NCT05437055

Disease control Sponsor: Penumbra Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests a device called the Penumbra System with Thunderbolt Aspiration Tubing to remove blood clots in people having a severe stroke caused by a blockage in a large brain artery. The goal is to see if the device can safely and effectively restore blood flow within 8 hours of symptoms starting. Participants are adults aged 18 to 80 who are eligible for mechanical thrombectomy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Penumbra System with Thunderbolt Aspiration Tubing (mechanical thrombectomy device)
What this could lead to
If successful, this device could improve blood flow restoration in stroke patients, potentially reducing brain damage and disability.
What could go wrong
This is a device study without a control group, so benefits may not be proven. Risks include vessel damage, bleeding, or failure to remove the clot.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

216 people

The number who actually took part.

Started

Aug 2022

Finished

Dec 2024

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.

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: 1. Patient age 18 - 80 years 2. Treatment within 8 hours of symptom onset 3. Pre-stroke mRS 0-2 4. Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion in the internal carotid, middle cerebral (M1 or M2), basilar, or vertebral artery 5. If patient is eligible for thrombolytic therapy, it was administered as soon as possible, and no later than 3 hours from stroke symptom onset 6. Planned frontline treatment with Penumbra System including Thunderbolt modulated aspiration 7. Informed consent obtained per Institution Review Board/Ethics Committee requirements Exclusion Criteria: 1. Stenosis, excessive tortuosity, or any occlusion in a proximal vessel requiring treatment or preventing access to the thrombus 2. Alberta Stroke Program Early CT Score (ASPECTS) ≤6 or core infarct volume \>50 mL on MRI or CT-based imaging (for anterior circulation strokes) 3. Pregnant patient 4. Life expectancy \< 90 days due to comorbidities 5. Current participation in an interventional drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies 6. 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.

cerebral artery occlusion ischemic stroke large artery stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke Large vessel occlusion

Contacts and locations

Locations

  • Abbott Northwestern

    Minneapolis, Minnesota, 55427, United States

  • Abrazo West Campus

    Goodyear, Arizona, 85395, United States

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Christiana Care

    Newark, Delaware, 19718, United States

  • Christus Trinity Medical Center

    Tyler, Texas, 75702, United States

  • Edward Elmhurst Health

    Naperville, Illinois, 60540, United States

  • Fort Sanders

    Knoxville, Tennessee, 37916, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • HRI - Swedish

    Englewood, Colorado, 80113, United States

  • Indiana U. Health

    Indianapolis, Indiana, 46202, United States

  • Jackson Memorial (U. of Miami)

    Miami, Florida, 33136, United States

  • KUMC

    Kansas City, Kansas, 66160, United States

  • MUSC

    Charleston, South Carolina, 29425, United States

  • Massachusetts General

    Boston, Massachusetts, 02114, United States

  • Methodist U.

    Memphis, Tennessee, 38104, United States

  • Nebraska Medical

    Omaha, Nebraska, 68198, United States

  • New Hanover Regional

    Wilmington, North Carolina, 28401, United States

  • North Shore U.

    Evanston, Illinois, 60201, United States

  • Piedmont Hospital Atlanta

    Atlanta, Georgia, 30309, United States

  • Riverside Regional Medical Center

    Newport News, Virginia, 23601, United States

  • Sharp Grossmont

    San Diego, California, 92123, United States

  • St. Dominic

    Jackson, Mississippi, 39216, United States

  • St. Joseph - BayCare

    Tampa, Florida, 33614, United States

  • Stonybrook U.

    Stony Brook, New York, 11794, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • UT Houston

    Houston, Texas, 77030, United States

  • University of Buffalo

    Buffalo, New York, 14203, United States

  • Valley Medical Center

    Renton, Washington, 98055, United States

  • Wellspan York

    York, Pennsylvania, 17403, United States

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060, United States

  • Yale New Haven

    New Haven, Connecticut, 06520, United States

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