Status:
UNKNOWN
Versi Retriever Approving Trial in Japan
Lead Sponsor:
Kobe City General Hospital
Conditions:
Stroke, Acute
Eligibility:
All Genders
20-85 years
Phase:
NA
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04129203
Start Date
February 1 2019
End Date
December 31 2021
Last Update
November 3 2020
Active Locations (1)
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1
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan, 650-0047