UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019251 |
|---|---|
| Receipt number | R000022247 |
| Scientific Title | J-Open caRdiac aortic arCH disEase replacement Surgical TheRApy Study |
| Date of disclosure of the study information | 2015/10/13 |
| Last modified on | 2016/06/23 14:17:21 |
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Basic information
Public title
J-Open caRdiac aortic arCH disEase
replacement Surgical TheRApy Study
Acronym
J-Open cardiac aortic arch disease
replacement surgical therapy study
Scientific Title
J-Open caRdiac aortic arCH disEase
replacement Surgical TheRApy Study
Scientific Title:Acronym
J-Open cardiac aortic arch disease
replacement surgical therapy study
Region
| Japan |
Condition
Condition
Thoracic aorta disease.
Aortic aneurysm,Aortic
dissection,Traumatic aortic injury.
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of
the treatment with Open Stent Graft
to the conventional arch replacement
surgery intended for the thoracic aorta
disease of the distal aortic arch to the
proximal descending aorta.
*The conventional arch replacement
surgery: The concomitant
conventional elephant trunk technique
is included.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Early and late all-cause death and mortality
Key secondary outcomes
(1) Incidence rate for Early MAE
(2) Incidence rate for Late MAE
(3) Changes in diameter of aneurysm
and dissection, and thrombosis
(4) Procedure related time evaluation
(5) Incidence rate for the secondary
procedure and data evaluation
(6) Incidence rate for OSG related AE
(Early, Late)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Patients age at the time of
obtaining informed consent more than
20 years of age
(2) Patients being able to undergo all
the post-op medical follow-ups
(3) Patients willing to sign the
informed consent by myself or legal
representative out of their own free
will
Key exclusion criteria
(1)Patients who are unable to undergo
the open heart surgery with the
cardiopulmonary bypass (including
cerebral vascular or cerebral nerve
damage)
(2) Patients who are unable to
undergo the surgery due to severe
anemia or abnormality of hemostasis
(3) Patients who are unable to
undergo the surgery due to the
infection (including the aortic infection)
(4) High-risk patients for the surgery
due to Shaggey aorta
(5) Patients who are expected to have
OSG placed at the distal position lower
than Th8.
(6) Patients who are disqualified by PI
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Okita |
Organization
J-OSG Study Group
Division name
Department of Cardiovascular Surgery,Kobe University Graduate School of Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-City, Hyogo, 650-0017, Japan
TEL
078-382-5942
j.osg.study@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | J-ORCHESTRA Study Administrative Office |
Organization
J-ORCHESTRA Study Administrative Office
Division name
Meditrix Corporation
Zip code
Address
1-18-14, Nihombashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL
0120-291-701
Homepage URL
http://j-orchestra.net/
j-osg@meditrix.jp
Sponsor or person
Institute
J-OSG Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan Lifeline Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 10 | Month | 13 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, Open, Prospective, Control Study
To confirm the survival including clinical symptom and complication in the early period from surgery to discharge and in the late postoperative period at 6, 12, 24 and 36 months.
Management information
Registered date
| 2015 | Year | 10 | Month | 06 | Day |
Last modified on
| 2016 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022247
