UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020057 |
|---|---|
| Receipt number | R000023159 |
| Scientific Title | Clinical Study of Thoracic Endovascular Repair for Aortic Arch Aneurysms with Surgeon-Modified Fenestrated and Retrograde Branched Device |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2021/12/07 10:40:25 |
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Basic information
Public title
Clinical Study of Thoracic Endovascular Repair for Aortic Arch Aneurysms with Surgeon-Modified Fenestrated and Retrograde Branched Device
Acronym
Clinical Study of Thoracic Endovascular Repair for Aortic Arch Aneurysms with Surgeon-Modified Fenestrated and Retrograde Branched Device
Scientific Title
Clinical Study of Thoracic Endovascular Repair for Aortic Arch Aneurysms with Surgeon-Modified Fenestrated and Retrograde Branched Device
Scientific Title:Acronym
Clinical Study of Thoracic Endovascular Repair for Aortic Arch Aneurysms with Surgeon-Modified Fenestrated and Retrograde Branched Device
Region
| Japan |
Condition
Condition
Aortic Arch or Distal Arch Aneurysms
Classification by specialty
| Vascular surgery | Radiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate the peri-operative clinical outcomes and
long-term clinical outcomes of thoracic endovascular repair for aortic arch aneurysms with surgeon-modified fenestrated and retrograde branched device
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rates of aortic disease related
death at 12 months post-procedure
Key secondary outcomes
Device Success, Procedural Time, Condit Usage During The Procedure, Clinical Utility Measures, Morbidity, Including The Composite Rate Of Major Adverse Events, Endoleak, Change In Aneurysm Size, Migration, Device Patency, Device Integrity
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
Treat aortic arch aneurysms with surgeon-modified fenestrated and retrograde branched stent graft and follow up with patients for 12 months post-operatively.
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
1) Aortic arch fusiform aneurysm with diameter >50 mm
2) Aortic arch fusiform aneurysm with a history of growth >5 mm per year
3) Aortic arch saccular aneurysm with 1.5 times the diameter as compared to the normal size
Key exclusion criteria
<General Exclusion Criteria>
1) Less than 20 years of age
2) Pregnant or patients likely to have been pregnant
3) Life expectancy less than 1 years
4) Unwilling to company with the follow up schedule
5) Inability or refusal to give informed consent
*Additionally, there is Medical Exclusion Criteria and Anatomical Exclusion Criteria, too.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Satoshi |
Organization
Shimane Prefectural Central Hospital
Division name
Department of Cardiovascular Surgery
Zip code
6938555
Address
4-1-1 Himebara, Izumo City, Shimane, Japan
TEL
0853-22-5111
kamihira@spch.izumo.shimane.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Satoshi |
Organization
Shimane Prefectural Central Hospital
Division name
Department of Cardiovascular Surgery
Zip code
6938555
Address
4-1-1 Himebara, Izumo City, Shimane, Japan
TEL
0853-22-5111
Homepage URL
kamihira@spch.izumo.shimane.jp
Sponsor or person
Institute
Shimane Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane Prefectural Central Hospital
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
Shimane Prefectural Central Hospital
Address
4-1-1 Himebara, Izumo City, Shimane, Japan
Tel
0853-22-5111
chiken@spch.izumo.shimane.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 | 12 | Month | 03 | 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
15
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
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2021 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023159
