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

Completed · Not applicable

Conditions studied: Acute Ischemic Stroke, Large Vessel Occlusion

In brief

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.

Key facts

Study ID

NCT05437055

Run by

Penumbra Inc.

People needed

216

Starts

2022-08-11

Expected to finish

2024-12-10

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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