UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032602 |
|---|---|
| Receipt number | 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 13:08:14 |
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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
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
shinichi18548342@gmail.com
Sponsor or person
Institute
Department of Radiology, Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037169
