UMIN-CTR Clinical Trial

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
Email	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
Email	kamihira@spch.izumo.shimane.jp

Sponsor
Institute	Shimane Prefectural Central Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023159