UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022312
Receipt No. R000025707
Scientific Title Computational Fluid Dynamics study for EXploring hemodynamic parameters Predicting REcanalization of cerebral aneurysmS one year after coil embolizationS (CFD-EXPRESS)
Date of disclosure of the study information 2016/05/15
Last modified on 2020/06/29 (Ver. 6)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information
Public title Computational Fluid Dynamics study for EXploring hemodynamic parameters Predicting REcanalization of cerebral aneurysmS one year after coil embolizationS (CFD-EXPRESS)
Acronym Computational Fluid Dynamics study for EXploring hemodynamic parameters Predicting REcanalization of cerebral aneurysmS one year after coil embolizationS (CFD-EXPRESS)
Scientific Title Computational Fluid Dynamics study for EXploring hemodynamic parameters Predicting REcanalization of cerebral aneurysmS one year after coil embolizationS (CFD-EXPRESS)
Scientific Title:Acronym Computational Fluid Dynamics study for EXploring hemodynamic parameters Predicting REcanalization of cerebral aneurysmS one year after coil embolizationS (CFD-EXPRESS)
Region
Japan

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

Objectives
Narrative objectives1 To explore the hemodynamic parameters predicting recanalization of cerebral aneurysms one-year after coil embolizations.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hemodynamic parameters, shape parameters and embolization parameters that are related to the recanalization one-year after the embolization of cerebral aneurysms
Key secondary outcomes

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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Unruptured internal carotid artery aneurysms that are embolized with detachable coils between 2013/1/1 and 2017/3/31.
Key exclusion criteria Aneurysms located in the cavernous sinus.
Aneurysms presenting with neurological symptoms.
Aneurysms embolized with stents.
Aneurysms without pre-operative 3D images.
Aneurysms that were judged to be inappropriate for this study by local investigators.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Masaaki
Middle name
Last name Shojima
Organization The University of Tokyo Hospital
Division name Department of Neurosurgery
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan.
TEL 03-5800-8853
Email mshoji-tky@umin.ac.jp

Public contact
Name of contact person
1st name Masaaki
Middle name
Last name Shojima
Organization The University of Tokyo Hospital
Division name Department of Neurosurgery
Zip code 1138655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan.
TEL 03-5800-8853
Homepage URL
Email mshoji-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization The University of Tokyo Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The University of Tokyo, Clinical Research Review Board
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel 03-5841-0818
Email ethics@m.u-tokyo.ac.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 広南病院（宮城県）
神戸中央市民医療センター（兵庫県）
順天堂大学医学部附属順天堂病院（東京都）
東京医科歯科大学医学部附属病院（東京都）
東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 15 Day

Related information
URL releasing protocol http://www.dummy.co.jp
Publication of results Unpublished

Result
URL related to results and publications http://dummy.co.jp/
Number of participants that the trial has enrolled 0
Results 
The research was terminated due to the transfer of the primary investigator.
Results date posted
2019 Year 11 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
none
Participant flow 
none
Adverse events 
none
Outcome measures 
none
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2016 Year 04 Month 12 Day
Date of IRB
2016 Year 04 Month 18 Day
Anticipated trial start date
2016 Year 04 Month 18 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information multicenter, retrospective and prospective observational study

Management information
Registered date
2016 Year 05 Month 14 Day
Last modified on
2020 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025707