The primary objective of this study is to demonstrate safety and effectiveness of the Penumbra System in a population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Study Type
OBSERVATIONAL
Enrollment
23
Penumbra System
RIA
Englewood, Colorado, United States
Tampa General Hospital/USF
Tampa, Florida, United States
mTICI Score
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score of 2b or higher. mTICI scale ranges from 0 to 3 with higher values representing better outcomes.
Time frame: Immediate Post Procedure
Functional Subject Outcome
Good functional subject outcome at 90 days post-procedure as defined by modified Rankin Scale (mRS) 0-2. mRS scale from from 0 to 6 with higher values representing a worse outcome.
Time frame: 90 days post
All-cause mortality at 90 days
All-cause mortality at 90 days
Time frame: 90 days
Safety: Device and procedure related SAE
Incidence of device and procedure related Serious Adverse Events (SAEs)
Time frame: Up to 30 days Post Procedure
Safety: Occurrence of ENT
Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure
Time frame: Immediate Post Procedure
Safety: Occurrence of Symptomatic intracranial hemorrhage
Occurrence of symptomatic hemorrhages (sICH) at 24 hours
Time frame: Up to 24 Hours Post Procedure
Procedural Time
Time from the arterial puncture to revascularization defined by mTICI 2b or greater
Time frame: Immediate Post Procedure
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Stroke Onset to Revascularization
Time from stroke onset to revascularization defined by mTICI 2b or greater
Time frame: Immediate Post Procedure
Complete Revascularization
Complete revascularization, defined as mTICI 2c and 3
Time frame: Immediate Post Procedure
Length of index hospital stay
Time frame: Up to 90 days Post Procedure
Type of Discharge Facility
Time frame: Up to 90 days Post Procedure