To confirm efficacy and safety of VERSI system for acute ischemic stroke
Efficacy; TICI 2a or more recanalization upto 3 pass of study device Safety; symptomatic intracranial hemorrhage within 24 hours of procedure
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
mechanical thrombectomy
Kobe City General Hospital
Kobe, Hyōgo, Japan
incidence of treatment-related severe adverse event
symptomatic intracranial hemorrhage
Time frame: within 24 hours after procedure
recovery to independent life {modified Rankin score of 2 or less]
Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less
Time frame: 90days after procedure
all intracralnial hemorrhage
incidence of symptomatic and asymptomatic intracranial hemorrhage
Time frame: within 24 hours after procedure
acceptable clinical outcome
Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less or back to baseline of mRS
Time frame: 90days after procedure
Severe adverse event related to device
Any severe adverse event related to device
Time frame: within 24 hours after procedure
recanalization ability of device
rate of immediate reperfusion with the device upto 3 path measured using Thrombolysis in Cerebrovascular Infarction (TICI) score of 2b or greater
Time frame: immediatry after procedure
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