Aortic arch disease
Conditions
Interventions
Use of Bolton arch branch stent-graft
Sponsors
Suita Tokushukai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The maximum diameter of the fusiform aneurysm exceeds 50 mm 2. Saccular aneurysm is judged to be at risk of rupture 3. Aneurysm shows a rapid expansion trend (>5 mm / year) 4. Symptoms (pain, organ perfusion injury etc.) 5. Others, there is a risk of rupture or organ perfusion failure and treatment is deemed necessary
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Avoidance of rupture and expansion for aortic aneurysm in 6 months after the procedure | — |
Countries
Japan
Contacts
Public ContactTomoaki Kudo
Suita Tokushukai Hospital Cardiovascular
Outcome results
None listed