ext-gen Fenestrated Endgraft to seek indication Expansion for arch aneurysm treatment
- Conditions
- Thoracic aortic aneurysm with unsuitable anatomy for endovascular repair using current stent-grafts
- Registration Number
- JPRN-UMIN000007213
- Lead Sponsor
- Tokyo Women's Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Aneurysm related event-free survival rate at one year
- Secondary Outcome Measures
Name Time Method Evaluation of the efficacy and safety such as primary success rate and rate of major complication