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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033522
Receipt No. 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 2018/07/26

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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
Middle name
Last name Junji Nakazawa
Organization Sapporo Medical University of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address Hokkaido prefecture Sapporo City South 1 West 16
TEL 0116112111
Email bankara02@chic.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junji Nakazawa
Organization Sapporo Medical University of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address Hokkaido prefecture Sapporo City South 1 West 16
TEL 0116112111
Homepage URL
Email bankara02@chic.ocn.ne.jp

Sponsor
Institute Sapporo Medical University of Medicine
Department of Cardiovascular Surgery
Institute
Department

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
Address
Tel
Email

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
2018 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038224

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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