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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027625
Receipt No. R000031652
Scientific Title Usefulness of a new sealing type stent-graft for abdominal aortic aneurysm (type 2 endoleak)
Date of disclosure of the study information 2017/06/10
Last modified on 2017/06/03

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Basic information
Public title Usefulness of a new sealing type stent-graft for abdominal aortic aneurysm (type 2 endoleak)
Acronym Study of a sealing type stent-graft for abdominal aortic aneurysm
Scientific Title Usefulness of a new sealing type stent-graft for abdominal aortic aneurysm (type 2 endoleak)
Scientific Title:Acronym Study of a sealing type stent-graft for abdominal aortic aneurysm
Region
Japan

Condition
Condition abdominal aortic aneurysm
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the efficacy of stent-graft (avoidance of type II endoleak)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes avoidance of type II endoleak
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Device: Nellix
30 days
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

Not applicable
Gender Male and Female
Key inclusion criteria AAA: 0ver 50mm
Key exclusion criteria Rupture
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Sawa
Organization Osaka University
Division name Cardiovascular Surgery
Zip code
Address 2-2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3154
Email sawa@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Shimamura
Organization Osaka University
Division name Cardiovascular Surgery
Zip code
Address 2-2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3154
Homepage URL
Email shimamura@surg1.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Osaka University
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 YES
Study ID_1 16470
Org. issuing International ID_1 Osaka University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 10 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
2017 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 03 Day
Last modified on
2017 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031652

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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