acute ischemic stroke
Conditions
Interventions
mechanical thrombectomy using Versi Retriever
Sponsors
Kobe City Medical Center General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 acute onset neurological symptom related to occluded vessel 2 within 8 hours from onset to treatment or within 24 hours from onset to treatment with imaging diagnosis 3 contra-indication or failed to intravenous rt-PA 4 accessible occlusion at ICA, MCA, VA, BA, PCA 5 5-30 of NIHSS 6 0-2 of mRS before onset 7 obtain documented informed content
Exclusion criteria
Exclusion criteria: 1 following condition; arterial dissection, engird, inaccessible turtuousity, difficult access by 50% or more stenosis, acute intracranial hemorrhage, space occping lesion or brain tumor, major early ischemic change in brain 2 occlude 2 major vessel territory 3 allege for contrast media, 4 abnormal PTT/APTT within 4 hours intravenous heparin 5 hemorrhagic tendency or 3 or more INR with Warfarin administration 6 30000cc or less of Platelet 7 50mg/dL or less of blood sugar 8 uncontrolled blood pressure, 185mmHg or more at systolic, 110mmHg or more at diastolic 9 90days or less life expancy 10 pregnant or lactating 11 join another trial of medicine or medical device 12 ineligible for trail
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Good clinical outcome (modified Rankin score 0-2) and death 90days after procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 successful recanalization after 3 passes of device 2 successful recanalization after procedure 3 new territory emolization related to procedure 4 symptomatic and asymtomatic intracranial hemorrhage 24 hours after procedure 5 symptomatic intracranial hemorrhage 24 hours after procedure 6 good clinical outcome (mRS 0-2 or 10 or more improvement of NIHSS) 90 days after procedure 7 severe adverse event related to device and procedure 90 days after procedure 8 mRS and NIHSS 90days after onset | — |
Countries
Japan
Contacts
Public ContactNobuyuki Sakai
Kobe City Medical Center General Hospital Neurosurgery
Outcome results
None listed