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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023866
Receipt No. 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 2016/08/31

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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
Middle name
Last name Takao Ohki
Organization The Jikei University school of medicine
Division name Department of surgery
Zip code
Address Minatoku Nishishinbashi 3-19-18 Tokyo Japan
TEL 03-3433-1111
Email reo.takizawa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Reo TAkizawa
Organization The Jikei University school of medicine
Division name Department of surgery
Zip code
Address Arakawaku Nishiogu 2-311 Tokyo Japan
TEL 03-3800-9175
Homepage URL
Email reo.takizawa@gmail.com

Sponsor
Institute The Jikei University school of medicine Department of surgery Devision of Vascular surgery
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2015 Year 12 Month 02 Day
Last follow-up date
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
2016 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.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


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