Acute Ischemic Stroke ischemic stroke, large vessel occlusion
Conditions
Interventions
endovascular treatment
Sponsors
SAKAI NOBUYUKI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 acute ischemic stroke within 24 hours from onset and pre-stroke modified Rankin Scale 3 or less and baseline NIHSS 30 or more 2 ICA/M1/VA/BA occlusion (eTICI 0 or 1) 3 use study system at first pass 4 age 18 to 90 5 obtain documented consent and agreement
Exclusion criteria
Exclusion criteria: 1 suspected arterial dissection, arteritis or atherosclerotic lesion 2 50% or more proximal stenosis or severe tourtuos anatomy 3 target artery diameter 2mm or less 4 associate intracranial hemorrhage, known hemorrhagic disease, coaglation disorder, oral anticoagrant PT-INR 3.0 or more, APTT 2 times by normal range 5 sBP 185 or more, dBP 110 or more, uncontolled 6 BS 50mg/dL or less 7 allegy to contrast 8 2 or more major arterial territory occulsion (R and L ICA, VABA) 9 life expancy within 90days 10 another interventional trial candidate 11 inappropriate candidate decided by researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy; Successful recanalization (eTICI 2b50 or better, upto 3 passes) Safety; Device related adverse event within 7 (-2/ +3) days after procedure, espcially distal emboliza tion, symptomatic dissection, vasospasm, and perf oration, hemorrgaic stroke | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. technical sucess 2. time from puncture to procedure end 3. first pass effect (eTICI 2c or better) 4. successful recanalization (eTICI 2b50 or better) 5. successful recanalization (eTICI 2n67 ore better) 6. symptomatic intracranial hemorrhage within 24 hours (NIHSS 4 or more worsened) 7. adverse event within 7 (-2/+3) days 8. mRS 7days after procedure 9. severe adverse event within 90days 10. mortality within 90days 11. mRS 90days after procedure | — |
Contacts
Public ContactYURIKO WATABE
Institute of kyoto Medical Research
Outcome results
None listed