THUNDER: Acute Ischemic Stroke Study with the Penumbra System® Including Thunderbolt™ Aspiration Tubing

Last updated: January 27, 2025
Sponsor: Penumbra Inc.
Overall Status: Completed

Phase

N/A

Condition

Stroke

Blood Clots

Cerebral Ischemia

Treatment

Mechanical Thrombectomy (Penumbra System with Thunderbolt)

Clinical Study ID

NCT05437055
21340
  • Ages 18-80
  • All Genders

Study Summary

The objective of this study is to demonstrate the safety and efficacy of the Penumbra System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy.

Eligibility Criteria

Inclusion

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 vesselocclusion in the internal carotid, middle cerebral (M1 or M2), basilar, or vertebralartery

  5. If patient is eligible for thrombolytic therapy, it was administered as soon aspossible, and no later than 3 hours from stroke symptom onset

  6. Planned frontline treatment with Penumbra System including Thunderbolt modulatedaspiration

  7. Informed consent obtained per Institution Review Board/Ethics Committee requirements

Exclusion

Exclusion Criteria:

  1. Stenosis, excessive tortuosity, or any occlusion in a proximal vessel requiringtreatment or preventing access to the thrombus

  2. Alberta Stroke Program Early CT Score (ASPECTS) ≤6 or core infarct volume >50 mL onMRI 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 confoundthe results of this study. Studies requiring extended follow-up for products thatwere investigational but have since become commercially available are not consideredinvestigational studies

  6. Other medical, behavioral, or psychological conditions that in the opinion of theInvestigator could limit the patient's ability to participate in the study,including compliance with follow-up requirements, or that could impact thescientific integrity of the study

Study Design

Total Participants: 216
Treatment Group(s): 1
Primary Treatment: Mechanical Thrombectomy (Penumbra System with Thunderbolt)
Phase:
Study Start date:
August 11, 2022
Estimated Completion Date:
December 10, 2024

Connect with a study center

  • Abrazo West Campus

    Goodyear, Arizona 85395
    United States

    Site Not Available

  • Sharp Grossmont

    San Diego, California 92123
    United States

    Site Not Available

  • HRI - Swedish

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Yale New Haven

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Christiana Care

    Newark, Delaware 19718
    United States

    Site Not Available

  • Jackson Memorial (U. of Miami)

    Miami, Florida 33136
    United States

    Site Not Available

  • St. Joseph - BayCare

    Tampa, Florida 33614
    United States

    Site Not Available

  • Piedmont Hospital Atlanta

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Wellstar Kennestone Hospital

    Marietta, Georgia 30060
    United States

    Site Not Available

  • North Shore U.

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Edward Elmhurst Health

    Naperville, Illinois 60540
    United States

    Site Not Available

  • Indiana U. Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • KUMC

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Massachusetts General

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • UMass Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Abbott Northwestern

    Minneapolis, Minnesota 55427
    United States

    Site Not Available

  • St. Dominic

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Nebraska Medical

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • University of Buffalo

    Buffalo, New York 14203
    United States

    Site Not Available

  • Stonybrook U.

    Stony Brook, New York 11794
    United States

    Site Not Available

  • New Hanover Regional

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Wellspan York

    York, Pennsylvania 17403
    United States

    Site Not Available

  • MUSC

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Fort Sanders

    Knoxville, Tennessee 37916
    United States

    Site Not Available

  • Methodist U.

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • UT Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Christus Trinity Medical Center

    Tyler, Texas 75702
    United States

    Site Not Available

  • Riverside Regional Medical Center

    Newport News, Virginia 23601
    United States

    Site Not Available

  • Valley Medical Center

    Renton, Washington 98055
    United States

    Site Not Available

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