To evaluate the efficacy and safety of catheter-based thrombectomy for reperfusion by removing a thrombus in a cerebral blood vessel in patients with acute cerebral infarction (within 8 hours after onset), in whom intravenous administration of tissue plasminogen activator (t-PA) is not indicated or reperfusion cannot be achieved by intravenous t-PA administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Kurume University Hospital
Kurume, Fukuoka, Japan
Brain Attack Center Ota Memorial Hospital
Fukuyama, Hiroshima, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
The primary efficacy endpoint of the study is rate of immediate post-procedure reperfusion with the device in 2 pathways/device or 3 pathways/vessel measured using Thrombolysis in Cerebrovascular Infarction (TICI) score of 2a or greater.
Time frame: immediate post procedure
The primary safety endpoint of the study is mortality within 90 days after the procedure
Time frame: 90 days
Proportion of subjects with newly diagnosed embolism accompanied by immediate post-procedure embolectomy
Time frame: immediate post-procedure
Rate of reperfusion not accompanied by symptomatic intracranial hemorrhage within 24 hours after the procedure
Time frame: 24 hours
Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or greater whose National Institute of Health Stroke Scale (NIHSS) score improved by 10 points or more from baseline at 90 days post-procedure
Time frame: 90 days
Assessment of mRS scores at 90 days post-procedure
Time frame: 90 days
Assessment of NIHSS scores at 90 days post-procedure
Time frame: 90 days
Assessment of Barthel Index (BI) scores at 90 days post-procedure
Time frame: 90 days
Incidence of intracranial hemorrhage including both symptomatic and asymptomatic within 24 hours after the procedure
Time frame: 24 hours
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Hyogo College of Medicine
Nishinomiya, Hyōgo, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Ise Red Cross Hospital
Ise, Mie-ken, Japan
Kohnan Hospital
Sendai, Miyagi, Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
Gifu University Hospital
Gifu, Japan
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, Japan
...and 3 more locations
Incidence of symptomatic intracranial hemorrhage within 24 hours after the procedure
Time frame: 24 hours
Incidence of asymptomatic intracranial hemorrhage within 24 hours after the procedure
Time frame: 24 hours
Incidence of device- or procedure-related serious adverse events within 90 days after the procedure
Time frame: 90 days
Number of any defect in the investigational device
Time frame: at the time of inspection before procedure, intraoperative and immediate post-procedure