UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025138 |
|---|---|
| Receipt number | R000028908 |
| Scientific Title | A multi-institutional survey of TEVAR for stanford typeB aortic dissection |
| Date of disclosure of the study information | 2016/12/05 |
| Last modified on | 2019/02/23 06:19:38 |
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Basic information
Public title
A multi-institutional survey of TEVAR for stanford typeB aortic dissection
Acronym
A multi-institutional survey of TEVAR for stanford typeB aortic dissection
Scientific Title
A multi-institutional survey of TEVAR for stanford typeB aortic dissection
Scientific Title:Acronym
A multi-institutional survey of TEVAR for stanford typeB aortic dissection
Region
| Japan |
Condition
Condition
Aortic dissection
Classification by specialty
| Cardiology | Vascular surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety and efficacy of TEVAR for Stanford typeB aortic dissection.
The effect of TEVAR for the affected abdominal branches.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The safety and efficacy of TEVAR for Stanford typeB aortic dissection.
The patency of abdominal branches following TEVAR
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
Thoracic Endovascular Aortic 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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with complicated Stanford typeB aortic dissetion who were treated by TEVAR at the participating institutions.
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Iwakoshi |
Organization
Nara Medical Unversity
Division name
Radiology
Zip code
Address
Sijyoutyou 840, Kashihara city, Nara prefecture, Japan
TEL
0744-29-8900
shinichi18548342@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Iwakoshi |
Organization
Nara Medical Unversity
Division name
Radiology
Zip code
Address
Sijyoutyou 840, Kashihara city, Nara prefecture, Japan
TEL
0744-29-8900
Homepage URL
shinichi18548342@gmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
The Japan Society of Aortic Stent Graft
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
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
奈良県立医科大学付属病院(奈良県)、大分大学医学部附属病院(大分県)、国立循環器センター(大阪府)、和歌山県立医科大学付属病院(和歌山県)、聖マリアンナ医科大学病院(神奈川県)、松原徳洲会病院(大阪府)、天理よろず相談所病院(奈良県)、姫路循環器病センター(兵庫県)、長崎大学病院(長崎県)、山口大学医学部付属病院(山口県)、森之宮病院(大阪府)、愛知医科大学病院(愛知県)、慶応義塾大学病院(東京都)、いわき市立総合磐城共立病院(福島県)、熊本大学医学部付属病院(熊本県)、済生会熊本病院(熊本県)、三重大学医学部附属病院(三重県)、手稲渓仁会病院(北海道)、北播磨総合医療センター(兵庫県)、神戸労災病院(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 05 | 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
| 2016 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028908
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