UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020473 |
|---|---|
| Receipt number | R000023234 |
| Scientific Title | EOLIA: Efficacy and safety Of EndovascuLar repair for abdominal and thoracIc aortic Aneurysms, a prospective multicenter observational study in Japan-Prospective multicenter registry- |
| Date of disclosure of the study information | 2016/01/07 |
| Last modified on | 2016/02/02 12:51:43 |
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Basic information
Public title
EOLIA: Efficacy and safety Of EndovascuLar repair for abdominal and thoracIc aortic Aneurysms, a prospective multicenter observational study in Japan-Prospective multicenter registry-
Acronym
EOLIA: Efficacy and safety Of EndovascuLar repair for abdominal and thoracIc aortic Aneurysms, a prospective multicenter observational study in Japan-Prospective multicenter registry (EOLIA)
Scientific Title
EOLIA: Efficacy and safety Of EndovascuLar repair for abdominal and thoracIc aortic Aneurysms, a prospective multicenter observational study in Japan-Prospective multicenter registry-
Scientific Title:Acronym
EOLIA: Efficacy and safety Of EndovascuLar repair for abdominal and thoracIc aortic Aneurysms, a prospective multicenter observational study in Japan-Prospective multicenter registry (EOLIA)
Region
| Japan |
Condition
Condition
Patients presenting AAA (Abdominal aortic aneurysm) or TAA (Thoracic aortic aneurysm) who are treated with EVAR (Endovascular Aneurysm Repair) or TEVAR (Thoracic Endovascular Aneurysm repair)
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of EVAR and TEVAR for patients presenting TAA or EVAR
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Five-years Mortality
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Obtaining informed consent for participant
2) Planning for EVAR or TEVAR
3) Agreement for long-term follow-up
Key exclusion criteria
1) Younger than 20 years old
2) Pregnancy or lactating
3) Allergy for stemless steel or nitinol metal
4) Prior history for treatment of aneurysm using stent graft
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Japan Labour Health and Welfare
Organization,
Kansai Rosai Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-69 Inabaso, Amagasaki-shi, 660-3511 Japan
TEL
0664161221
iida.osa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Japan Labour Health and Welfare Organization, Kansai Rosai Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-69 Inabaso, Amagasaki-shi, 660-3511
TEL
0664161221
Homepage URL
iida.osa@gmail.com
Sponsor or person
Institute
EOLIA
Institute
Department
Personal name
Funding Source
Organization
none
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
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
関西労災病院(兵庫県）、京都大学医学部附属病院 （京都府）、大阪赤十字病院 （大阪府）、
大津赤十字病院（滋賀県）、神戸市立医療センター中央市民病院（兵庫県）、神戸労災病院（兵庫県）、済生会八幡総合病院（福岡県）、静岡県立総合病院（静岡県）、島根県立中央病院 （島根県）、広島原爆赤十字病院（広島県）、松山赤十字病院（愛媛県）、水戸済生会病院（茨木県）、
大垣市民病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | 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
| 2015 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | 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
Management information
Registered date
| 2016 | Year | 01 | Month | 07 | Day |
Last modified on
| 2016 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023234
