UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033522 |
|---|---|
| Receipt number | R000038224 |
| Scientific Title | Late Open Surgical Graft Explantation can be safe option for sac expansion after EVAR |
| Date of disclosure of the study information | 2018/07/30 |
| Last modified on | 2022/12/21 21:23:36 |
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Basic information
Public title
Late Open Surgical Graft Explantation can be safe option for sac expansion after EVAR
Acronym
Open Surgical Graft Explantation after EVAR
Scientific Title
Late Open Surgical Graft Explantation can be safe option for sac expansion after EVAR
Scientific Title:Acronym
Open Surgical Graft Explantation after EVAR
Region
| Japan |
Condition
Condition
abdominal aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we evaluate the features of patients received an open graft explantation due to sac expansion following EVAR and the result of the procedure by comparing to the patients received an elective open graft explantation for AAA in our institution.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
surgical death
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
| 48 | years-old | <= |
Age-upper limit
| 88 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Group of elective surgical graft explantation and Group of surgical graft explantation after EVAR
Key exclusion criteria
emergency patients
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Nakazawa |
Organization
Sapporo Medical University of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
0608543
Address
Hokkaido prefecture Sapporo City South 1 West 16
TEL
0116112111
bankara02@chic.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Nakazawa |
Organization
Sapporo Medical University of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
0608543
Address
Hokkaido prefecture Sapporo City South 1 West 16
TEL
0116112111
Homepage URL
bankara02@chic.ocn.ne.jp
Sponsor or person
Institute
Sapporo Medical University of Medicine
Department of Cardiovascular Surgery
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Sapporo Medical Univercity
Address
Hokkaido prefecture Sapporo City South 1 West 16
Tel
0116112111
bankara02@gmail.com
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 | 07 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | 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
nothing
Management information
Registered date
| 2018 | Year | 07 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038224
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
