UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041589 |
|---|---|
| Receipt number | 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 | 2021/07/06 16:44:01 |
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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
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
chiakmk@cronos.ocn.ne.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 14 | Day |
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
| 2021 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047479
