UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	J-Open caRdiac aortic arCH disEase replacement Surgical TheRApy Study
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yutaka Okita
Organization	J-OSG Study Group
Division name	Department of Cardiovascular Surgery,Kobe University Graduate School of Medicine
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe-City, Hyogo, 650-0017, Japan
TEL	078-382-5942
Email	j.osg.study@gmail.com

Public contact
Name of contact person	J-ORCHESTRA Study Administrative Office
Organization	J-ORCHESTRA Study Administrative Office
Division name	Meditrix Corporation
Address	1-18-14, Nihombashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL	0120-291-701
Homepage URL	http://j-orchestra.net/
Email	j-osg@meditrix.jp

Sponsor
Institute	J-OSG Study Group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022247