Versi Retriever Approving Trial in Japan

Study Overview
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Brief Summary
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This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital.

Detailed Description
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This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital. 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.

Official Title
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Multi Center, Prospective, Registry Trial of Versi Retriever Mechanical Thrombecomy for Acute Ischemic Stroke in Japan

Conditions
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Stroke, Acute

Intervention / Treatment
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* Device: Versi Retriever thrombectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute onset neurological sympto m related to occluded vessel 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: following condition; arterial diss ection, engird, inaccessible turtuousity, difficult access by 50% or m ore stenosis, acute intracranial hemorrhage, space occuping lesion or brain tumor, major early ischemic change in brain 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial arm<br>Mechanical thrombectomy using Versi Retriever | Device: Versi Retriever thrombectomy<br>* Mechanical thrombectomy using Versi Retriever<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Good clinical outcome | modified Rankin Score is 0-2 | 90days after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful recanalization | TICI 2b-3 | at 3 passes of device in the procedure | 
| Successful recanalization | TICI 2b-3 | at end of procedure | 
| Symptomatic and asymptomatic intracranial hemorrhage | NIHSS 4 or more worsened | at 24 hours after procedure | 
| Good clinical outcome 2 | mRS 0-2 or NIHSS 10 or more improvement | 90days after procedure | 
| sever advers event | device or procedure related | 90days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke