The objective of this post-market registry is to assess technical efficacy and safety associated with the use of the BOSS Balloon Guide Catheter during neuro-vascular procedures while providing temporary arrest of blood flow.
This is a prospective, multi-center, non-randomized observational registry evaluating use of BOSS balloon guide catheters in patients diagnosed with an acute ischemic stroke due to large intracranial vessel occlusion.
Study Type
OBSERVATIONAL
Enrollment
52
Adjunctive device providing a conduit for retrieval device during thrombectomy
BNI (St. Joseph's Hospital-Dignity Health)
Phoenix, Arizona, United States
Swedish-RIACO
Englewood, Colorado, United States
Baptist Health Jacksonville
Jacksonville, Florida, United States
Northwestern University
Safety Evaluation
Incidence of device-related adverse events
Time frame: Hospital discharge or 7 days
Performance Evaluation
Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment
Time frame: Completion of procedure
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Chicago, Illinois, United States
KUMC
Kansas City, Kansas, United States
UMass Medical School
Worcester, Massachusetts, United States
University of Missouri
Columbia, Missouri, United States
Ft Sanders Regional Medical Center
Knoxville, Tennessee, United States
Carilion Clinic
Roanoke, Virginia, United States