Thrombectomy Revascularization of Intracranial Vessel OcclusioN by Originating From Japan (TRON1-Japan) "TRON1-Japan"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Thrombectomy Device T-01 Device
    ARM 1: Kind: Experimental
    Label: Thrombectomy Device(T-01)
    Description: Mechanical Thrombectomy with T-01

Outcomes

Type Measure Time Frame Safety Issue
Primary 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. immediate post procedure
Primary The primary safety endpoint of the study is mortality within 90 days after the procedure 90 days
Secondary Proportion of subjects with newly diagnosed embolism accompanied by immediate post-procedure embolectomy immediate post-procedure
Secondary Rate of reperfusion not accompanied by symptomatic intracranial hemorrhage within 24 hours after the procedure 24 hours
Secondary 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 90 days
Secondary Assessment of mRS scores at 90 days post-procedure 90 days
Secondary Assessment of NIHSS scores at 90 days post-procedure 90 days
Secondary Assessment of Barthel Index (BI) scores at 90 days post-procedure 90 days
Secondary Incidence of intracranial hemorrhage including both symptomatic and asymptomatic within 24 hours after the procedure 24 hours
Secondary Incidence of symptomatic intracranial hemorrhage within 24 hours after the procedure 24 hours
Secondary Incidence of asymptomatic intracranial hemorrhage within 24 hours after the procedure 24 hours
Secondary Incidence of device- or procedure-related serious adverse events within 90 days after the procedure 90 days
Secondary Number of any defect in the investigational device at the time of inspection before procedure, intraoperative and immediate post-procedure

Sponsors