Evaluation of Adjunctive Use of EndoAnchors During of After EVAR and TEVAR
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate of participants with type IA Endoleaks
研究概览
简要总结
EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed described to improve fixation (mimicking an open surgical anastomosis) during or after EVAR/TEVAR.
The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study)
详细描述
EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed designed to improve the Endovascular aortic repair. This device is described to mimic an open surgical anastomosis during or after EVAR/TEVAR.
The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study), these outcomes will be described in terms of type IA Endoleaks, migration and sac regression.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients with adjunctive use of EndoAnchors during or after EVAR and TEVAR
排除标准
- •Patients that don't want te receive any repair for their disease
结局指标
主要结局
Rate of participants with type IA Endoleaks
时间窗: Three years
Absence of type IA Endoleaks during follow-up
次要结局
- Rate of participants with Endograft Migration(Three years)
- Rate of participants with Sac regression(Three years)
研究者
Andrés Reyes Valdivia
Principal Investigator
Hospital Universitario Ramon y Cajal