UMIN-CTR Clinical Trial

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
Email	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
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	The Jikei University school of medicine
Address	Minatoku Nishishinbashi 3-19-18 Tokyo Japan
Tel	03-3433-1111
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023130