UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness and safety of branched type stent graft for aortic arch disease
Acronym	Effectiveness and safety of branched type stent graft
Scientific Title	Effectiveness and safety of branched type stent graft for aortic arch disease
Scientific Title:Acronym	Effectiveness and safety of branched type stent graft
Region	Japan

Condition
Condition	Aortic arch disease
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effectiveness and safety of branched type stent graft for aortic arch disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Avoidance of rupture and expansion for aortic aneurysm in 6 months after the procedure
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	Use of Bolton arch branch stent-graft
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. The maximum diameter of the fusiform aneurysm exceeds 50 mm 2. Saccular aneurysm is judged to be at risk of rupture 3. Aneurysm shows a rapid expansion trend (>5 mm / year) 4. Symptoms (pain, organ perfusion injury etc.) 5. Others, there is a risk of rupture or organ perfusion failure and treatment is deemed necessary
Key exclusion criteria	1. Underage (under 20) 2. Have clinically important untreated coronary artery disease and requires revascularization. 3. Severe cardiac dysfunction, left ventricular ejection fraction (LVEF) is less than 20% by echocardiography. 4. Pregnant. 5. Chronic obstructive pulmonary disease (COPD) is observed. 6. Have active systemic infection and / or infective aortic aneurysm. 7. Have a history of cerebrovascular disease (CVA) or transient cerebral ischemic attack (TIA) within one month from the scheduled surgical day. 8. Have active gastrointestinal bleeding. 9. Diagnosed as having less than one year of life expectancy based on a clear medical basis (presence of malignant tumor, age etc.). 10. Participate in clinical trials of other medical devices or drugs. 11.Refuse blood transfusion 12. Have severe dementia
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Shibuya
Organization	Suita Tokushukai Hospital
Division name	Cardiovascular
Zip code	565-0814
Address	21-1, Senriokak-Nishi, Suita, Osaka, Japan
TEL	06-6878-1110
Email	takashi.shibuya@tokushukai.jp

Public contact
Name of contact person	1st name Tomoaki Middle name Last name Kudo
Organization	Suita Tokushukai Hospital
Division name	Cardiovascular
Zip code	565-0814
Address	21-1, Senriokak-Nishi, Suita, Osaka, Japan
TEL	06-6878-1110
Homepage URL
Email	kudou-ygc@umin.ac.jp

Sponsor
Institute	Suita Tokushukai Hospital
Institute
Department

Funding Source
Organization	none
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	Mirai Iryo Research Center Inc.
Address	1-8-7, Koji-machi, Chiyoda-ku, Tokyo
Tel	03-3263-4801
Email	03-3263-4802

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	2018 Year 07 Month 05 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	Terminated
Date of protocol fixation	2017 Year 07 Month 07 Day
Date of IRB	2018 Year 03 Month 06 Day
Anticipated trial start date	2018 Year 07 Month 13 Day
Last follow-up date	2019 Year 09 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 05 Day
Last modified on	2020 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037959