UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033209 |
|---|---|
| Receipt number | R000037868 |
| Scientific Title | The Japanese Retrospective Multicenter Comparative Study of the Natural Course and TEVAR for Residual Dissection following Surgical Repair for TypeA Aortic Dissection. |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2018/11/22 03:27:51 |
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Basic information
Public title
The Japanese Retrospective Multicenter Comparative Study of the Natural Course and TEVAR for Residual Dissection following Surgical Repair for TypeA Aortic Dissection.
Acronym
The Japanese Retrospective Multicenter Comparative Study of the Natural Course and TEVAR for Residual Dissection following Surgical Repair for TypeA Aortic Dissection.
Scientific Title
The Japanese Retrospective Multicenter Comparative Study of the Natural Course and TEVAR for Residual Dissection following Surgical Repair for TypeA Aortic Dissection.
Scientific Title:Acronym
The Japanese Retrospective Multicenter Comparative Study of the Natural Course and TEVAR for Residual Dissection following Surgical Repair for TypeA Aortic Dissection.
Region
| Japan |
Condition
Condition
Aortic dissection
Classification by specialty
| Vascular surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impact of TEVAR for residual aortic dissection following surgical repair for Type A aortic dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
aortic diameter
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who undertook surgical operation for Stanford Type A aortic dissection from 2012 to 2017.
Key exclusion criteria
The patient who received TEVAR with handmade device.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Iwakoshi |
Organization
Nara Medical University
Division name
Radiology
Zip code
Address
Sijyoutyou 840, Kashihara city, Japan
TEL
0744298900
shinichi18548342@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Iwakoshi |
Organization
Nara Medical University
Division name
Radiology
Zip code
Address
Sijyoutyou 840, Kashihara city, Japan
TEL
0744298900
Homepage URL
shinichi18548342@gmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | 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
aortic diameter
Management information
Registered date
| 2018 | Year | 06 | Month | 30 | Day |
Last modified on
| 2018 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037868
