Phase
Condition
Stroke
Blood Clots
Cerebral Ischemia
Treatment
Mechanical Thrombectomy (Penumbra System with Thunderbolt)
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient age 18 - 80 years
Treatment within 8 hours of symptom onset
Pre-stroke mRS 0-2
Patient experiencing acute ischemic stroke secondary to intracranial large vesselocclusion in the internal carotid, middle cerebral (M1 or M2), basilar, or vertebralartery
If patient is eligible for thrombolytic therapy, it was administered as soon aspossible, and no later than 3 hours from stroke symptom onset
Planned frontline treatment with Penumbra System including Thunderbolt modulatedaspiration
Informed consent obtained per Institution Review Board/Ethics Committee requirements
Exclusion
Exclusion Criteria:
Stenosis, excessive tortuosity, or any occlusion in a proximal vessel requiringtreatment or preventing access to the thrombus
Alberta Stroke Program Early CT Score (ASPECTS) ≤6 or core infarct volume >50 mL onMRI or CT-based imaging (for anterior circulation strokes)
Pregnant patient
Life expectancy < 90 days due to comorbidities
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
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
Connect with a study center
Abrazo West Campus
Goodyear, Arizona 85395
United StatesSite Not Available
Sharp Grossmont
San Diego, California 92123
United StatesSite Not Available
HRI - Swedish
Englewood, Colorado 80113
United StatesSite Not Available
Yale New Haven
New Haven, Connecticut 06520
United StatesSite Not Available
Christiana Care
Newark, Delaware 19718
United StatesSite Not Available
Jackson Memorial (U. of Miami)
Miami, Florida 33136
United StatesSite Not Available
St. Joseph - BayCare
Tampa, Florida 33614
United StatesSite Not Available
Piedmont Hospital Atlanta
Atlanta, Georgia 30309
United StatesSite Not Available
Wellstar Kennestone Hospital
Marietta, Georgia 30060
United StatesSite Not Available
North Shore U.
Evanston, Illinois 60201
United StatesSite Not Available
Edward Elmhurst Health
Naperville, Illinois 60540
United StatesSite Not Available
Indiana U. Health
Indianapolis, Indiana 46202
United StatesSite Not Available
KUMC
Kansas City, Kansas 66160
United StatesSite Not Available
Massachusetts General
Boston, Massachusetts 02114
United StatesSite Not Available
UMass Memorial Medical Center
Worcester, Massachusetts 01655
United StatesSite Not Available
Abbott Northwestern
Minneapolis, Minnesota 55427
United StatesSite Not Available
St. Dominic
Jackson, Mississippi 39216
United StatesSite Not Available
Nebraska Medical
Omaha, Nebraska 68198
United StatesSite Not Available
Albany Medical Center
Albany, New York 12208
United StatesSite Not Available
University of Buffalo
Buffalo, New York 14203
United StatesSite Not Available
Stonybrook U.
Stony Brook, New York 11794
United StatesSite Not Available
New Hanover Regional
Wilmington, North Carolina 28401
United StatesSite Not Available
Geisinger Medical Center
Danville, Pennsylvania 17822
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Wellspan York
York, Pennsylvania 17403
United StatesSite Not Available
MUSC
Charleston, South Carolina 29425
United StatesSite Not Available
Fort Sanders
Knoxville, Tennessee 37916
United StatesSite Not Available
Methodist U.
Memphis, Tennessee 38104
United StatesSite Not Available
UT Houston
Houston, Texas 77030
United StatesSite Not Available
Christus Trinity Medical Center
Tyler, Texas 75702
United StatesSite Not Available
Riverside Regional Medical Center
Newport News, Virginia 23601
United StatesSite Not Available
Valley Medical Center
Renton, Washington 98055
United StatesSite Not Available
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