THUNDER: Acute Ischemic Stroke Study with the Penumbra System® Including Thunderbolt™ Aspiration Tubing
NCT ID: NCT05437055
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
216 participants
INTERVENTIONAL
2022-08-11
2024-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy
Mechanical Thrombectomy (Penumbra System with Thunderbolt)
Subject will receive Penumbra System with Thunderbolt
Interventions
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Mechanical Thrombectomy (Penumbra System with Thunderbolt)
Subject will receive Penumbra System with Thunderbolt
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Penumbra Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Donald Frei, M.D.
Role: PRINCIPAL_INVESTIGATOR
HCA HealthONE, LLC (Swedish Medical Center)
David Fiorella, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Research Foundation for The State University of New York (Stony Brook University)
Locations
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Abrazo West Campus
Goodyear, Arizona, United States
Sharp Grossmont
San Diego, California, United States
HRI - Swedish
Englewood, Colorado, United States
Yale New Haven
New Haven, Connecticut, United States
Christiana Care
Newark, Delaware, United States
Jackson Memorial (U. of Miami)
Miami, Florida, United States
St. Joseph - BayCare
Tampa, Florida, United States
Piedmont Hospital Atlanta
Atlanta, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
North Shore U.
Evanston, Illinois, United States
Edward Elmhurst Health
Naperville, Illinois, United States
Indiana U. Health
Indianapolis, Indiana, United States
KUMC
Kansas City, Kansas, United States
Massachusetts General
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Abbott Northwestern
Minneapolis, Minnesota, United States
St. Dominic
Jackson, Mississippi, United States
Nebraska Medical
Omaha, Nebraska, United States
Albany Medical Center
Albany, New York, United States
University of Buffalo
Buffalo, New York, United States
Stonybrook U.
Stony Brook, New York, United States
New Hanover Regional
Wilmington, North Carolina, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Wellspan York
York, Pennsylvania, United States
MUSC
Charleston, South Carolina, United States
Fort Sanders
Knoxville, Tennessee, United States
Methodist U.
Memphis, Tennessee, United States
UT Houston
Houston, Texas, United States
Christus Trinity Medical Center
Tyler, Texas, United States
Riverside Regional Medical Center
Newport News, Virginia, United States
Valley Medical Center
Renton, Washington, United States
Countries
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Other Identifiers
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21340
Identifier Type: -
Identifier Source: org_study_id
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