Versi Retriever Approving Trial in Japan
Multi Center, Prospective, Registry Trial of Versi Retriever Mechanical Thrombecomy for Acute Ischemic Stroke in Japan
1 other identifier
interventional
58
1 country
1
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 Center General Hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
October 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedNovember 3, 2020
November 1, 2020
2.2 years
March 12, 2019
November 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Good clinical outcome
modified Rankin Score is 0-2
90days after procedure
Secondary Outcomes (5)
Successful recanalization
at 3 passes of device in the procedure
Successful recanalization
at end of procedure
Symptomatic and asymptomatic intracranial hemorrhage
at 24 hours after procedure
Good clinical outcome 2
90days after procedure
sever advers event
90days after procedure
Study Arms (1)
Trial arm
EXPERIMENTALMechanical thrombectomy using Versi Retriever
Interventions
Eligibility Criteria
You may qualify if:
- 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
- of NIHSS
- of mRS before onset
- obtain documented informed co ntent
You may not qualify if:
- 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
- cc or less of Platelet
- mg/dL or less of blood sugar
- uncontrolled blood pressure, 185mmHg or more at systolic, 110m mHg or more at diastolic
- days or less life expancy
- pregnant or lactating
- join another trial of medicine or medical device
- ineligible for trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nobuyuki Sakai, MD DMSc
Kobe City Medical Center General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Neurosurgery
Study Record Dates
First Submitted
March 12, 2019
First Posted
October 16, 2019
Study Start
February 1, 2019
Primary Completion
March 31, 2021
Study Completion
December 31, 2021
Last Updated
November 3, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share