The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Registry Objective: The primary objective of this registry is to collect real-world performance and safety data on Penumbra System including the 3D Revascularization Device in a patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO). Registry Design: This will be a prospective, single-arm, multi-center observational registry and will include patients that present with either anterior or posterior LVO who are eligible for mechanical thrombectomy using the Penumbra System. Registry Duration: Subjects will be in the registry for approximately 90 days from enrollment to last follow-up.
Study Type
OBSERVATIONAL
Enrollment
650
Penumbra System
mTICI Score
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score 2b or higher. mTICI scale ranges 0 to 3 higher values represent better outcomes.
Time frame: Post Procedure
Functional Subject Outcome
Functional subject outcome at 90 days post-procedure as defined by a modified Rankin Scale (mRS) 0-2. mRS scale ranges 0 to 6 higher values represent a worse outcome.
Time frame: 90 days post
All-cause mortality at 90 days
All-cause mortality at 90 days
Time frame: 90 days
Incidence of device and procedure related Serious Adverse Events (SAEs)
Time frame: Within 24 hours of procedure
Occurrence of embolization in previously uninvolved (or new) territories (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: During Procedure
Occurrence of symptomatic intracranial hemorrhages (sICH)
Time frame: 24 Hours Post Procedure
Time to Revascularization
Time frame: During Procedure
Length of hospital stay
Time frame: Through discharge, up to study completion at approximately 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Banner Desert Medical Center
Mesa, Arizona, United States
Eden Medical Center
Castro Valley, California, United States
St. Jude Medical Center
Fullerton, California, United States
Cedar Sinai Medical Center
Los Angeles, California, United States
Mercy San Juan Medical Center
Sacramento, California, United States
Los Robles Hospital
Thousand Oaks, California, United States
RIA
Englewood, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Jackson Memorial Hospital
Miami, Florida, United States
Naples Community Hospital
Naples, Florida, United States
...and 32 more locations
Discharge Facility
Time frame: Through discharge, up to study completion at approximately 90 days