UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023866 |
|---|---|
| Receipt number | R000023130 |
| Scientific Title | Aortic Arch Aneurysms repair with a branched Thoracic Arch Graft (a-Branch) |
| Date of disclosure of the study information | 2016/08/31 |
| Last modified on | 2021/09/04 11:05:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Aortic Arch Aneurysms repair with a branched Thoracic Arch Graft (a-Branch)
Acronym
Aortic Arch Aneurysms repair with a branched Thoracic Arch Graft(a-Branch)
Scientific Title
Aortic Arch Aneurysms repair with a branched Thoracic Arch Graft (a-Branch)
Scientific Title:Acronym
Aortic Arch Aneurysms repair with a branched Thoracic Arch Graft(a-Branch)
Region
| Japan |
Condition
Condition
Aortic arch aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To present initial experience with a new modular transfemoral multibranched stent graft for treating aortic arch aneurysms in japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success and 30-day mortality
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
TEVAR with BCA stentgraft and CCA stentgraft
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,Surgical repair is an aortic arch aneurysm considered to be a requirement.
2,The diameters of an ascending aorta which landing BranchedThoracicArchGraft are 30 mm or more of outside diameters, and 42 mm or less.
3.BranchedThoracicArchGraft; the proximal/distal side of a landding part is not Aneurysm (the vessel diameter should not be changing 10% or more).
4.An access vessel (a neck branched, an iliac artery, or femoral artery) fit to delivery system of a device (20Fr-23Fr) by which the distantia (internal diameter) and shape (the thrombus, a mineralization, or kink) are used.
You may use conduit, when an access is poor.
The distantia of STJ and a brachiocephalic trunk is 35 mm or more.
A test subject's year old is a male aged 20 and over or female.
They are not a pregnant, a lactating, or the women that is planning the tecnogony within 24 months.
Furthermore, the urine or serum pregnancy test on less than the 7th is negative before a technique.
I can observe the specified followup evaluation schedule.
Key exclusion criteria
1.Exsistance of vascular injury which poses clinical problem
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Ohki |
Organization
The Jikei University school of medicine
Division name
Department of surgery
Zip code
105-8461
Address
Minatoku Nishishinbashi 3-19-18 Tokyo Japan
TEL
03-3433-1111
reo.takizawa@gmail.com
Public contact
Name of contact person
| 1st name | Reo |
| Middle name | |
| Last name | Takizawa |
Organization
The Jikei University school of medicine
Division name
Department of surgery
Zip code
105-8461
Address
Minatoku Nishishinbashi 3-19-18 Tokyo Japan
TEL
03-3433-1111
Homepage URL
reo.takizawa@gmail.com
Sponsor or person
Institute
The Jikei University school of medicine Department of surgery Devision of Vascular surgery
Institute
Department
Personal name
Funding Source
Organization
The Jikei University school of medicine Department of surgery Devision of Vascular surgery
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
The Jikei University school of medicine
Address
Minatoku Nishishinbashi 3-19-18 Tokyo Japan
Tel
03-3433-1111
reo.takizawa@gmail.com
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
| 2016 | Year | 08 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 31 | Day |
Last modified on
| 2021 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023130
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
