UMIN-CTR Clinical Trial

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

Thoracic aorta disease.
Aortic aneurysm,Aortic
dissection,Traumatic aortic injury.

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

j.osg.study@gmail.com

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/

Email

j-osg@meditrix.jp

Institute

J-OSG Study Group

Institute

Department

Personal name

Organization

Japan Lifeline Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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