JPRN-UMIN000007213招募中2 期
ext-gen Fenestrated Endgraft to seek indication Expansion for arch aneurysm treatment - TEVAR using Next-gen Fenestrated Endgraft
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •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
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