UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014619 |
|---|---|
| Receipt number | R000016007 |
| Scientific Title | Multi-center registry of endovascular abdominal aortic repair |
| Date of disclosure of the study information | 2014/07/23 |
| Last modified on | 2014/07/23 12:08:41 |
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Basic information
Public title
Multi-center registry of endovascular abdominal aortic repair
Acronym
EVAR registry
Scientific Title
Multi-center registry of endovascular abdominal aortic repair
Scientific Title:Acronym
EVAR registry
Region
| Japan |
Condition
Condition
abdominal aortic aneurysm
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate the peri-operative clinical outcomes and long-term clinical outcomes of endovascular abdominal aortic repair.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The rates of aortic disease related death
Key secondary outcomes
All-cause death
Diameter reduction rates of aneurysm
Procedure related adverse event
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent endovascular abdominal aortic repair
Key exclusion criteria
No exclusion
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimura Takeshi |
Organization
Kyoto University
Division name
department of circulation
Zip code
Address
54 Shogoin Kawaharacho Sakyo-ku Kyoto 606-8507 Japan
TEL
075-751-4255
taketaka@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tazaki Junichi |
Organization
Kyoto University
Division name
department of circulation
Zip code
Address
54 Shogoin Kawaharacho Sakyo-ku Kyoto 606-8507 Japan
TEL
075-751-4255
Homepage URL
jun1@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine,
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Severe adverse events after endovascular aortic repair will be reported.
Management information
Registered date
| 2014 | Year | 07 | Month | 23 | Day |
Last modified on
| 2014 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016007
