UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050383 |
|---|---|
| Receipt number | R000057370 |
| Scientific Title | Comparison of Rupture Risk Between Saccular and Fusiform Abdominal Aortic Aneurysms Using a National Clinical Database in Japan |
| Date of disclosure of the study information | 2023/02/20 |
| Last modified on | 2023/02/19 11:09:48 |
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Basic information
Public title
Comparison of Rupture Risk Between Saccular and Fusiform Abdominal Aortic Aneurysms Using a National Clinical Database in Japan
Acronym
Risk of Rupture in Saccular Abdominal Aortic Aneurysms
Scientific Title
Comparison of Rupture Risk Between Saccular and Fusiform Abdominal Aortic Aneurysms Using a National Clinical Database in Japan
Scientific Title:Acronym
Risk of Rupture in Saccular Abdominal Aortic Aneurysms
Region
| Japan |
Condition
Condition
Abdominal aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a survey of saccular abdominal aortic aneurysms and to compare the risk of rupture between fusiform and saccular abdominal aortic aneurysms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the aneurysm diameter at which saccular AAAs were operated on by EVAR in the non-ruptured and ruptured cases.
Key secondary outcomes
The secondary outcomes included the odds ratio of saccular morphology for becoming ruptured and a cut-off value of aneurysm diameter for predicting the rupture of a saccular AAA.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent endovascular repair for an abdominal aortic aneurysm between 2016 and 2019, using the National Clinical Database in Japan.
Key exclusion criteria
Patients with an aneurysm diameter < 25 mm were excluded from the study.
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Ozawa |
Organization
The Jikei University School of Medicine
Division name
Vascular Surgery
Zip code
105-8461
Address
3-25-8, Nishi-shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
hirotsugu_ozawa@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Ozawa |
Organization
The Jikei University School of Medicine
Division name
Vascular Surgery
Zip code
105-8461
Address
3-25-8, Nishi-shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
hirotsugu_ozawa@yahoo.co.jp
Sponsor or person
Institute
The Jikei University School of Medicine
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
The Jikei University School of Medicine
Address
3-25-8, Nishi-shinbashi, Minato-ku, Tokyo
Tel
03-3433-1111
hirotsugu_ozawa@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 20 | 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
27290
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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 02 | Month | 19 | Day |
Last modified on
| 2023 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057370
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
