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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035632
Receipt No. R000040591
Scientific Title Prospective, multi-center, trial of mechanical thrombectomy for acute ischemic stroke using Versi Retriever
Date of disclosure of the study information 2019/01/24
Last modified on 2019/01/23

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Basic information
Public title Prospective, multi-center, trial of mechanical thrombectomy for acute ischemic stroke using Versi Retriever
Acronym Prospective trial of Versi Thrombectomy (VERTH)
Scientific Title Prospective, multi-center, trial of mechanical thrombectomy for acute ischemic stroke using Versi Retriever
Scientific Title:Acronym Prospective trial of Versi Thrombectomy (VERTH)
Region
Japan

Condition
Condition acute ischemic stroke
Classification by specialty
Neurology Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm efficacy and safety of mechanical thrombectomy for acute ischemic stroke using Versi retriever
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Good clinical outcome (modified Rankin score 0-2) and death 90days after procedure
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 mechanical thrombectomy using Versi Retriever
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key 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
Key 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
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Sakai
Organization Kobe City Medical Center General Hospital
Division name Neurosurgery
Zip code
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL 078-302-4321
Email n.sakai@siren.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Sakai
Organization Kobe City Medical Center General Hospital
Division name Neurosurgery
Zip code
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL 078-302-4321
Homepage URL
Email n.sakai@siren.ocn.ne.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) NeuroVasc Co

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 広南病院、筑波大学、埼玉医科大学国際医療センター、京都大学、大阪医療センター、兵庫医科大学、神戸市立医療センター中央市民病院、

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 06 Month 30 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 01 Month 23 Day
Last modified on
2019 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040591

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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