This study is to test a hypothesis that temporary implantation of JRecanTM blood flow recanalisation device within 6.5 hours of symptom onset of acute ischemic stroke due to a major intracranial artery occlusion following IV r-tPA can provide a greater rate of early successful recanalisation than treatment of IV r-tPA alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
JRecanTM blood flow recanalisation device
intravenous recombinant human tissue plasminogen activator
Early successful recanalisation (assessed by the imaging core laboratory)
TIMI(thrombolysis in myocardial infarction)2 or 3 recanalisation 1 hour after enrollment blindly assessed by the imaging core laboratory and without any presence of symptomatic intracranial hemorrhage within 24 hours blindly assessed by independent neurologists.
Time frame: 24 hours
Good neurological outcome( modified Rankin Scale (mRS) score ≤2, or National Institutes of Health Stroke Scale(NIHSS)score improvement of 10 points or more)
modified Rankin Scale (mRS) score ≤2, or National Institutes of Health Stroke Scale(NIHSS)score improvement of 10 points or more.
Time frame: 90 days
Incidence of device related and procedure-related serious adverse events(SAEs)
The incidence of device related and procedure-related serious adverse events(SAEs)
Time frame: 30 days
Additional safety end-points (symptomatic intracranial haemorrhage at 24 hours, and Death due to any cause at 90 days)
symptomatic intracranial haemorrhage at 24 hours, and Death due to any cause at 90 days
Time frame: 90 days
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