UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041023
Receipt number R000046848
Scientific Title Japanese Society of Neuroendovascular Therapy Data Base - PulseRider and W-EB registry
Date of disclosure of the study information 2020/07/07
Last modified on 2020/07/07 13:41:36

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Basic information

Public title

Japanese Society of Neuroendovascular Therapy Data Base - PulseRider and W-EB registry

Acronym

JSNET-DB - PulseRider and W-EB registry

Scientific Title

Japanese Society of Neuroendovascular Therapy Data Base - PulseRider and W-EB registry

Scientific Title:Acronym

JSNET-DB - PulseRider and W-EB registry

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 PulseRider and W-EB

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

complete occlusion without aneurysm rupture and re-treatment at 1 year after treatment

Key secondary outcomes

1 neurological death within 30 days after treatment
2 major stroke within 30 days after treatment
3 complete occlusion without aneurysm rupture and re-treatment at 3 years after treatment
4 aneurysm rupture or re-treatment within 3 years after treatment
5 aneurysm recanalization or growth within 3 years after treatment
6 re-treatment within 3 years after treatment
7 major stroke in the territory within 3 years after treatment
8 hemorrhagic event or 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

patient who is scheduled or completed to endovascular treatment for intracranial aneurysm using PulseRider or W-EB

Key exclusion criteria

no limitation

Target sample size

600


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

650-0047

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

650-0047

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 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

Japan


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 07 Month 07 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 04 Month 27 Day

Date of IRB

2020 Year 05 Month 14 Day

Anticipated trial start date

2020 Year 07 Month 07 Day

Last follow-up date

2023 Year 12 Month 31 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 PulseRider and W-EB


Management information

Registered date

2020 Year 07 Month 07 Day

Last modified on

2020 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046848


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name