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Effectiveness and safety of branched type stent graft for aortic arch disease

Not Applicable
Conditions
Aortic arch disease
Registration Number
JPRN-UMIN000033298
Lead Sponsor
Suita Tokushukai Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

Exclusion Criteria

1. Underage (under 20) 2. Have clinically important untreated coronary artery disease and requires revascularization. 3. Severe cardiac dysfunction, left ventricular ejection fraction (LVEF) is less than 20% by echocardiography. 4. Pregnant. 5. Chronic obstructive pulmonary disease (COPD) is observed. 6. Have active systemic infection and / or infective aortic aneurysm. 7. Have a history of cerebrovascular disease (CVA) or transient cerebral ischemic attack (TIA) within one month from the scheduled surgical day. 8. Have active gastrointestinal bleeding. 9. Diagnosed as having less than one year of life expectancy based on a clear medical basis (presence of malignant tumor, age etc.). 10. Participate in clinical trials of other medical devices or drugs. 11.Refuse blood transfusion 12. Have severe dementia

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Avoidance of rupture and expansion for aortic aneurysm in 6 months after the procedure
Secondary Outcome Measures
NameTimeMethod
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