NCT05721001进行中（未招募）不适用
NEO - E-vita Open Neo Treatment of Aortic Arch Aneurysms and Dissections
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- JOTEC GmbH
- 入组人数
- 130
- 试验地点
- 23
- 主要终点
- Mortality
研究概览
简要总结
Observational, prospective/retrospective, non-randomised, non-comparative, multicentre cohort study.
Primary objective is evaluation of in-hospital all-cause mortality after treatment of extensive acute and chronic aortic pathologies with E-vita OPEN NEO.
详细描述
Objectives
Primary objective:
• Evaluation of in-hospital all-cause mortality after treatment of extensive acute and chronic aortic pathologies with E-vita OPEN NEO
Secondary objective:
• Evaluation of the morbi-mortality in-hospital, 1 year and 3 years follow-up after treatment of extensive acute and chronic aortic pathologies with E-vita OPEN NEO.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-objection from the patient for data collection within this Registry
- •patient treated with E-vita Open NEO
排除标准
- •objection from the patient for data collection within this Registry
结局指标
主要结局
Mortality
时间窗: through study completion, an average of 3 years
Rate of in-hospital all-cause mortality
次要结局
- Mortality(1 year and 3 years)
- Neurological complications(At discharge, an average of 45 days, 1 year, 3 years)
- Reinterventions(1 year, 3 years)
- Severe Adverse Events(3 years)
- Stroke(At discharge, an average of 45 days, 1 year, 3 years)
- Paraplegia(At discharge, an average of 45 days, 1 year, 3 years)
- Renal Insufficiency(At discharge, an average of 45 days, 1 year, 3 years)
- Entry flow(At discharge, an average of 45 days, 1 year, 3 year)
- Morbidity(1 year and 3 year)
- Paraparesis(At discharge, an average of 45 days, 1 year, 3 years)
- Permeability(1 year, 3 years)
- Endoleaks(At discharge, an average of 45 days, 1 year, 3 years)
- Malperfusion(At discharge, an average of 45 days, 1 year, 3 years)
- Bleeding(At discharge, an average of 45 days, 1 year, 3 years)
- False Lumen(At discharge, an average of 45 days, 1 year, 3 year)
- Additional interventions(1 year, 3 year)
研究者
研究点 (23)
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