Status:
COMPLETED
THUNDER: Acute Ischemic Stroke Study with the Penumbra System® Including Thunderbolt™ Aspiration Tubing
Lead Sponsor:
Penumbra Inc.
Conditions:
Acute Ischemic Stroke
Large Vessel Occlusion
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2024
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT05437055
Start Date
August 11 2022
End Date
December 10 2024
Last Update
January 29 2025
Active Locations (32)
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1
Abrazo West Campus
Goodyear, Arizona, United States, 85395
2
Sharp Grossmont
San Diego, California, United States, 92123
3
HRI - Swedish
Englewood, Colorado, United States, 80113
4
Yale New Haven
New Haven, Connecticut, United States, 06520