UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027625 |
|---|---|
| Receipt number | 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 | 2020/01/17 17:42:04 |
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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 | Yoshiki |
| Middle name | |
| Last name | Sawa |
Organization
Osaka University
Division name
Cardiovascular Surgery
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3154
sawa@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Shimamura |
Organization
Osaka University
Division name
Cardiovascular Surgery
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3154
Homepage URL
shimamura@surg1.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
Osaka University
Address
2-2, Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
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
9
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
| 2017 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031652
