NCT03594786Unknown不适用
To Assess Hemodynamic Disturbances to the Ostia of the Renal Arteries Generated by the Implantation of EVAR With a Suprarenal Fixation
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- systolic maximum speed at the ostia of the renal arteries
研究概览
简要总结
The investigators conducted a bicentric prospective study to quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation EVAR with suprarenal fixation immediately postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective EVAR with supra renal fixation
- •women who have been postmenopausal for at least 24 months or are surgically sterilized, or for women of childbearing potential, use of an effective method of contraception
- •consent to participate
- •Affiliation to a French social security
排除标准
- •stenosis of at least one renal artery
- •rupture of abdominal aortic aneurysm
- •renal stenting during the procedure
- •fenestrated EVAR
- •legal incapacity or limited legal capacity
- •subject being in the exclusion period of another study
- •pregnant woman
结局指标
主要结局
systolic maximum speed at the ostia of the renal arteries
时间窗: one month
Quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of a suprarenal fixation aortic stent immediately postoperatively.
次要结局
- proportion of decrease of the resistance index(one year)
- proportion of disappearance of the "notch" (pre-systolic notch)(one year)
- systolic maximum speed at the ostia of the renal arteries(one year)
- proportion of patients with renal artery stenosis(one year)
- proportion of increase in systolic rise time(one year)
- proportion of post-stenotic turbulence(one year)
- glomerular filtration rate(one year)
研究者
研究点 (2)
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