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J-Open caRdiac aortic arCH disEase replacement Surgical TheRApy Study

J-Open caRdiac aortic arCH disEase replacement Surgical TheRApy Study - J-Open cardiac aortic arch disease replacement surgical therapy study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000019251
Enrollment
600
Registered
2015-10-13
Start date
2015-07-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Sponsors

J-OSG Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Early and late all-cause death and mortality

Secondary

MeasureTime frame
(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)

Countries

Japan

Contacts

Public ContactJ-ORCHESTRA Study Administrative Office

J-ORCHESTRA Study Administrative Office Meditrix Corporation

j-osg@meditrix.jp0120-291-701

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026