Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy of the stenting in terms of aneurysm thrombosis rate
研究概览
简要总结
This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.
The enrollment period will be of 65 months (01/jan/2020-30/jun/2025). Sample size will be of 100 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •patients who are hemodynamically unstable or show CT signs of rupture or contained rupture of visceral aneurysm
- •pregnant or breastfeeding women
- •life expectancy less than 2 years
结局指标
主要结局
Efficacy of the stenting in terms of aneurysm thrombosis rate
时间窗: 12 months
aneurysm (partial or complete, \>50% or 100%) thrombosis
Safety in terms of morbidity
时间窗: 12 months
morbidity (any adverse events occured during follow up for any causes and by causes associated with treatment)
Safety in terms of mortality
时间窗: 12 months
mortality (any cause of death related to pathology or not)
Safety in terms of technical issues
时间窗: 12 months
technical issues (any adverse event during stent placement)
Efficacy of the stenting in terms of patency and side branches
时间窗: 12 months
stent patency and side branches (the absence of stenosis greater than 50% of the stent's internal lumen and the side branches' lumen)
Efficacy of the stenting in terms of aneurysm volume assessment
时间窗: 12 months
aneurysm volume assessment (percentage of volume reduction respect to the initial volume)
次要结局
未报告次要终点