Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
58 participants
INTERVENTIONAL
2019-02-01
2021-12-31
Brief Summary
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Detailed Description
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60 cases will be enrolled and 90 days follow up need. Primary endpoint is favorable clinical outcome, mRS 0-2. Secondary endpoint are mortality in 90days, immediate successful recanalization, TICI 2b-3, symptomatic intracranial hemorrhage, and any adverse event related to device and or procedure.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trial arm
Mechanical thrombectomy using Versi Retriever
Versi Retriever thrombectomy
Mechanical thrombectomy using Versi Retriever
Interventions
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Versi Retriever thrombectomy
Mechanical thrombectomy using Versi Retriever
Eligibility Criteria
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Inclusion Criteria
* within 8 hours from onset to tre atment or within 24 hours from onset to treatment with imaging diagnosis
* contra-indication or failed to int ravenous rt-PA
* accessible occlusion at ICA, MC A, VA, BA, PCA
* 5-30 of NIHSS
* 0-2 of mRS before onset
* obtain documented informed co ntent
Exclusion Criteria
* occlude 2 major vessel territory
* allege for contrast media,
* abnormal PTT/APTT within 4 h ours intravenous heparin
* hemorrhagic tendency or 3 or more INR with Warfarin administration
* 30000cc or less of Platelet
* 50mg/dL or less of blood sugar
* uncontrolled blood pressure, 185mmHg or more at systolic, 110m mHg or more at diastolic
* 90days or less life expancy
* pregnant or lactating
* join another trial of medicine or medical device
* ineligible for trial
20 Years
85 Years
ALL
No
Sponsors
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Kobe City General Hospital
OTHER
Responsible Party
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Nobuyuki Sakai
Director, Neurosurgery
Principal Investigators
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Nobuyuki Sakai, MD DMSc
Role: STUDY_CHAIR
Kobe City Medical Center General Hospital
Locations
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Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VS-01
Identifier Type: -
Identifier Source: org_study_id