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

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Description

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.

Study Overview

Start Date
August 11, 2022
Completion Date
June 1, 2025
Enrollment
275
Date Posted
June 29, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Sharp Grossmont
San Diego, California 92123, United States

HRI - Swedish
Englewood, Colorado 80113, United States

Yale New Haven
New Haven, Connecticut 06520, United States

Christiana Care
Newark, Delaware 19718, United States

Jackson Memorial (U. of Miami)
Miami, Florida 33136, United States

St. Joseph - BayCare
Tampa, Florida 33614, United States

Piedmont Hospital Atlanta
Atlanta, Georgia 30309, United States

Wellstar Kennestone Hospital
Marietta, Georgia 30060, United States

North Shore U.
Evanston, Illinois 60201, United States

Indiana U. Health
Indianapolis, Indiana 46202, United States

KUMC
Kansas City, Kansas 66160, United States

Massachusetts General
Boston, Massachusetts 02114, United States

UMass Memorial Medical Center
Worcester, Massachusetts 01655, United States

Abbott Northwestern
Minneapolis, Minnesota 55427, United States

University of Buffalo
Buffalo, New York 14203, United States

Stonybrook U.
Stony Brook, New York 11794, United States

Geisinger Medical Center
Danville, Pennsylvania 17822, United States

Thomas Jefferson University
Philadelphia, Pennsylvania 19107, United States

MUSC
Charleston, South Carolina 29425, United States

Fort Sanders
Knoxville, Tennessee 37916, United States

Methodist U.
Memphis, Tennessee 38104, United States

UT Houston
Houston, Texas 77030, United States

Christus Trinity Medical Center
Tyler, Texas 75702, United States

Riverside Regional Medical Center
Newport News, Virginia 23601, United States

Eligibility

Minimum Age (years)
18
Maximum Age (years)
80
Eligibility Criteria
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 vessel occlusion in the internal carotid, middle cerebral (M1 or M2), basilar, or vertebral artery
If patient is eligible for thrombolytic therapy, it was administered as soon as possible, and no later than 3 hours from stroke symptom onset
Planned frontline treatment with Penumbra System including Thunderbolt modulated aspiration
Informed consent obtained per Institution Review Board/Ethics Committee requirements

Exclusion Criteria:

Stenosis, excessive tortuosity, or any occlusion in a proximal vessel requiring treatment or preventing access to the thrombus
Alberta Stroke Program Early CT Score (ASPECTS) ≤6 or core infarct volume >50 mL on MRI 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 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
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

Study Contact Info

Study Contact Name
Ravi Radhakrishnan; Brooke Lawson
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
NCTid (if applicable)
NCT05437055