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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032602
Receipt No. R000037169
Scientific Title Multicenter Retrospective study of Interventional Radiology for Type2 endoleak following EVAR.
Date of disclosure of the study information 2018/05/15
Last modified on 2018/06/30

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Basic information
Public title Multicenter Retrospective study of Interventional Radiology for Type2 endoleak following EVAR.
Acronym Multicenter Retrospective study of Interventional Radiology for Type2 endoleak following EVAR.
Scientific Title Multicenter Retrospective study of Interventional Radiology for Type2 endoleak following EVAR.
Scientific Title:Acronym Multicenter Retrospective study of Interventional Radiology for Type2 endoleak following EVAR.
Region
Japan

Condition
Condition Abdominal aortic aneurysm
Classification by specialty
Vascular surgery Radiology Cardiovascular surgery
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the success rate of TAE for T2EL following EVAR and association between technical aspects and aneurysm diameter change.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Aneurysm diameter change following TAE
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The cases treated by EVAR using commercially available device and underwent aneurysm enlargement due to T2EL

The cases who underwent TAE for T2EL from January 2007 to December 2017.
Key exclusion criteria The cases who underwent surgical treatment for sac enlargement without TAE.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Iwakoshi
Organization Nara Medical University
Division name Radiology
Zip code
Address 840 Shijo-cho, Kashihara, Nara 634-8521, Japan
TEL 0744-29-8900
Email shinichi18548342@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Iwakoshi
Organization Nara Medical University
Division name Radiology
Zip code
Address 840 Shijo-cho, Kashihara, Nara 634-8521, Japan
TEL 0744-29-8900
Homepage URL
Email shinichi18548342@gmail.com

Sponsor
Institute Department of Radiology, Nara Medical University
Institute
Department

Funding Source
Organization Self Funding
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor St. Marianna University Hospital
Nagoya City University Hospital
Kanazawa University Hospital
Gifu University Hospital
Kitazato University Hospital
Tsukuba University Hospital
Iwate Medical University Hospital
Tokai University Hospital
Okinawa Chubu Hospital
Tenri Hospital
Tottori University Hospital
Yamanasi University Hospital
Aichi Medical University Hospital
Kumamoto University Hospital
Osaka University Hospital
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 15 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
2018 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information age, sex, aneurysm diameter, device used for EVAR, emboloic material for TAE,

Management information
Registered date
2018 Year 05 Month 15 Day
Last modified on
2018 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037169

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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