J-Open caRdiac aortic arCH disEase replacement Surgical TheRApy Study
Not Applicable
Recruiting
- Conditions
- Thoracic aorta disease. Aortic aneurysm,Aortic dissection,Traumatic aortic injury.
- Registration Number
- JPRN-UMIN000019251
- Lead Sponsor
- J-OSG Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Early and late all-cause death and mortality
- Secondary Outcome Measures
Name Time Method (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)