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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041589
Receipt No. R000047479
Scientific Title Japanese Society of Neuroendovascular Therapy Data Base - Pipeline PREMIER
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/28

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Basic information
Public title Japanese Society of Neuroendovascular Therapy Data Base - Pipeline PREMIER
Acronym JSNET-DB - Pipeline PREMIER
Scientific Title Japanese Society of Neuroendovascular Therapy Data Base - Pipeline PREMIER
Scientific Title:Acronym JSNET-DB - Pipeline PREMIER
Region
Japan

Condition
Condition Intracranial aneurysm
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate endovascular treatment for intracranial aneurysms using Pipeline Flex to new indication
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes complete occlusion without re-treatment and severe stenosis of parent artery at 12 month after treatment
Key secondary outcomes 1 major stroke in the territory or neurological death at 12 month after treatment
2 occurrence rate of neurological death at 30days, 6mo, 12mo, 24mo and 36mo after treatment
3 occurrence rate of major stroke in the territory at 30days, 6mo, 12mo, 24mo and 36mo after treatment
4 occurrence rate of delayed intracranial hemorrhage
5 success rate of delivery device
6 relation of anti-platelet and event
7 adverse event and device failure within 3 years after treatment

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 patient who is scheduled or completed to endovascular treatment for intracranial aneurysm using Pipeline Flex to
a. internal carotid artery: C2~C6 (AN diameter; 5mm to 10mm)
b. internal carotid artery: C7 (AN diameter; over 5mm)
c. vertebral artery: (AN diameter; over 5mm)
2 patient who has consent
Key exclusion criteria No limitation
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Sakai
Organization Kobe City Medical Center General Hospital
Division name Neurosurgery
Zip code 6500047
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 Chiaki
Middle name
Last name Sakai
Organization Kobe City Medical Center General Hospital
Division name Center for Clinical Research and Innovation
Zip code 6500047
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL 078-302-4321
Homepage URL
Email chiakmk@cronos.ocn.ne.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization Japanese Society of Neuoendovascular Therapy
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kobe City Medical Center General Hospital
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
Tel 078-302-4321
Email rinken@kcho.jp

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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 01 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
2020 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2026 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Registry of endovascular treatment for intracranial aneurysm using Pipeline Flex to new indication

Management information
Registered date
2020 Year 08 Month 28 Day
Last modified on
2020 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047479

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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