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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033298
Receipt No. R000037959
Official scientific title of the study Effectiveness and safety of branched type stent graft for aortic arch disease
Date of disclosure of the study information 2018/07/05
Last modified on 2018/07/05

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Basic information
Official scientific title of the study Effectiveness and safety of branched type stent graft for aortic arch disease
Title of the study (Brief title) 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 Takashi Shibuya
Organization Suita Tokushukai Hospital
Division name Cardiovascular
Address 21-1, Senriokak-Nishi, Suita, Osaka, Japan
TEL 06-6878-1110
Email takashi.shibuya@tokushukai.jp

Public contact
Name of contact person Tomoaki Kudo
Organization Suita Tokushukai Hospital
Division name Cardiovascular
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 07 Month 07 Day
Anticipated trial start date
2018 Year 07 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

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


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

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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