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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
216
Subject will receive Penumbra System with Thunderbolt
Efficacy Endpoint: Angiographic Revascularization
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by mTICI 2b or higher. \*mTICI ranges from 0-3, with higher grading representing better outcome
Time frame: Immediate Post Procedure
Efficacy Endpoint: Angiographic Revascularization After First Pass
Angiographic revascularization of the occluded target vessel after first pass as defined by mTICI 2b or higher \*mTICI ranges from 0-3, with higher grading representing better outcome
Time frame: Index Procedure
Efficacy Endpoint: Angiographic Revascularization
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by mTICI 2c or higher \*mTICI ranges from 0-3, with higher grading representing better outcome
Time frame: Immediate Post Procedure
Efficacy Endpoint: Time to Revascularization
Time to Revascularization
Time frame: Index Procedure
Efficacy Endpoint: Modified Rankin Scale (mRS)
Functional outcomes measured by mRS 0-2 at 90 days (0 no symptoms - 5 severe disability)
Time frame: 90 Days Post-Procedure
Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)
Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours
Time frame: 24 hours Post-Procedure
Safety Endpoint: All-cause mortality
All-cause mortality at 90 days
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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
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Piedmont Hospital Atlanta
Atlanta, Georgia, United States
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North Shore U.
Evanston, Illinois, United States
...and 22 more locations
Time frame: 90 Days Post-Procedure
Safety Endpoint: Serious Adverse Events (SAEs)
Incidence of device related, and/or procedure related Serious Adverse Events (SAEs) within 24 hours post-procedure
Time frame: Up to 24 hours Post-Procedure