UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033298 |
|---|---|
| Receipt number | R000037959 |
| Scientific Title | 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 | 2020/01/24 14:10:40 |
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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
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
kudou-ygc@umin.ac.jp
Sponsor or person
Institute
Suita Tokushukai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037959
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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