UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019662 |
|---|---|
| Receipt number | R000022722 |
| Scientific Title | Effectiveness and safety study of branched stent-graft for aortic arch disease |
| Date of disclosure of the study information | 2015/11/06 |
| Last modified on | 2020/10/16 16:07:36 |
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Basic information
Public title
Effectiveness and safety study of branched stent-graft for aortic arch disease
Acronym
Effectiveness and safety study of branched stent-graft for aortic arch disease
Scientific Title
Effectiveness and safety study of branched stent-graft for aortic arch disease
Scientific Title:Acronym
Effectiveness and safety study of branched stent-graft for aortic arch disease
Region
| Japan |
Condition
Condition
aortic arch disease
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the effectiveness and safety of branched stent graft for aortic arch disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
freedom from aortic rupture/enlargement at 6 month postoperatively
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Endovascular arotic repair
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
aortic arch pathologies in open repair high risk patient which are excluded from endovascular treatment using approved straight stent graft.
Key exclusion criteria
Patients who do not satisfy the anatomical inclusion criteria for branched device
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sawa |
| Middle name | |
| Last name | Yoshiki |
Organization
Osaka University Graduate School of Medicine
Division name
Department of cardiovascular surgery
Zip code
565-0871
Address
Yamadaoka 2-2, Suita
TEL
06-6879-3154
sawa@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shimamura |
| Middle name | |
| Last name | Kazuo |
Organization
Osaka University Graduate School of Medicine
Division name
Department of cardiovascular surgery
Zip code
565-0871
Address
Yamadaoka 2-2, Suita
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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Graduate School
Address
Yamadaoka 2-2, Suita
Tel
06-6210-8090
mirai@hp-mctr.med.osaka-u.ac.jp
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
| 2015 | Year | 11 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 06 | Day |
Last modified on
| 2020 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022722
