Thoracic aortic aneurysm with unsuitable anatomy for endovascular repair using current stent-grafts
Conditions
Interventions
All patients are undergone TEVAR(Thoracic Endovascular Aneurysm Repair) for thoracic aortic aneurysm.Tokyo Women'
s Medical University provide homemade stent graft to every institutes.
Sponsors
Tokyo Women's Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are identified as those with at least one of the following: 1,An thoracic aortic aneurysm more than 50 mm wide. 2,The aneurysm has enlarged by more than 5 mm in less than 12 months. 3,Saccular aneurysm larger than normal 10mm in maximum transverse diameter
Exclusion criteria
Exclusion criteria: 1,Less than 20 years old 2,Pregnant females 3,Estimated life expectancy of less than twelve months. 4,Never indicate thier intention 5,With NYHA class IV 6,Recent (within three (3) months) myocardial infarction. 7,Recent (within three months) Cerebral Vascular Accident (CVA). 8,Connective tissue disease (e.g., Marfans and Ehlers-Danlos syndrome). 9,History of bleeding diathesis(including high DIC score, more than 6, caused by aneurysm without palliative therapy) coagulopathy, or refuses blood transfusions. 10,Sensitivities or allergies to stainless steel, ePTFE, PVDF, contrast media, heparin. 11,With unclear cerebellar arteries circle of Willis ,who need to be blocked their subclavian artery with stent graft without bilateral suclavian artery bypass beforehand. 12,Never plan to be blocked their left subclavian artery with less than 10mm proximal landing zone from left subclavialn artery to aneurysm . 13,Never plan to be blocked their left carotid artery with less than 10mm proximal landing zone from left carotid artery to aneurysm. 14,Never plan to be blocked their brachiocephalic trunk with less than 10mm proximal landing zone from brachiocephalic trunk to aneurysm. 15,Plan to be blocked their celiac trunk with unclear connection from SMA to celiac trunk via pancreaticoduodenal arcade. 16,Plan to be blocked their celiac trunk with less than 15mm proximal landing zone from SMA to aneurysm. 17,Never plan to be blocked their celiac trunk with less than 15mm proximal landing zone from celiac trunk to aneurysm. 18,Unfavorable access route with calcification, stenosis and tortuous iliac. 19,Unfavorable landing zone with calcification, mural hematoma and athero. 20,Significant formation of atheroma in access route and are concerned with risk of atherothrombosis. 21,Thoracic aneurysm with a contained rupture. 22,With less than 18mm and more than 43mm aortic diameter in proximal landing zone. 23,With active systemic infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aneurysm related event-free survival rate at one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the efficacy and safety such as primary success rate and rate of major complication | — |
Countries
Japan
Contacts
Public ContactTakashi Azuma
Tokyo Women's Medical University Cardiovascularsurgery
Outcome results
None listed