UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031083 |
|---|---|
| Receipt number | R000035491 |
| Scientific Title | Japanese registry of patients treated with endovascular or open repair for ruptured abdominal aortic aneurysm |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2018/02/01 16:29:56 |
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Basic information
Public title
Japanese registry of patients treated with endovascular or open repair for ruptured abdominal aortic aneurysm
Acronym
JEWELRY study
Scientific Title
Japanese registry of patients treated with endovascular or open repair for ruptured abdominal aortic aneurysm
Scientific Title:Acronym
JEWELRY study
Region
| Japan |
Condition
Condition
Ruptured abdominal aortic aneurysm
Classification by specialty
| Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)To explore the patients' status, treatment procedure selection, and the clinical results in real-world clinical setting in Japan.
2) To clarify the adequate selection of EVAR or open repair for ruptured abdominal aortic aneurysms in reflecting the patients' situation and anatomical conditions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
30 days mortality
Key secondary outcomes
In-hospital mortality
30 days MACE
Length of hospital stay
Survival rate at 3 year
Aneursym-related even-free survival at 3 year
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
Ruptured abdominal aortic aneurysm
Key exclusion criteria
-Impending rupture case
-Aneurysm previously treated
-Ruptured aneurysm of external or internal iliac artery
-Supra-renal aortic aneurysm
-Died before entering operation room
-Patient who do not agree to be enrolled in this study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyoshi Azuma |
Organization
Asahikawa Medical University
Division name
Department of Vascular Surgery
Zip code
Address
Midorigaoka Higash i2-1-1-1 Asahikawa Hokkaido
TEL
0166-68-2494
nazuma@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chigusa Yamamoto |
Organization
The Japanese Society for Vascular Surgery
Division name
Office
Zip code
Address
Odakyudaiichiseimei Bld. 4F nishishinjyuku2-7-1 shinjyuku Tokyo
TEL
03-5989-0991
Homepage URL
http://www.jsvs.org/ja/enquete/aaa/
jsvs@jhf.or.jp
Sponsor or person
Institute
The Japanese Society for Vascular Surgery
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society for Vascular Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japanese Committee for Stentgraft Management
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
旭川医科大学（北海道）、名古屋大学（愛知県）、東京慈恵会医科大学（東京都）、関西医科大学（大阪府）、弘前大学（青森県）、山口大学（山口県）、信州大学（長野県）、湘南鎌倉総合病院（神奈川県）、森の宮病院（大阪府）、他約100施設
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.jsvs.org/ja/enquete/aaa/
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
| 2017 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | 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
This study is cooperatively managed by Japanese Society of Vascular Surgery and Japanese Committee of Stentgraft Management
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2018 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035491
| Research Plan | |
|---|---|
| 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 |
