NL-OMON53733招募中不适用
Randomized controlled clinical trial on the application of Heli-FX EndoAnchors in conjunction with the Endurant II/IIs endograft in infrarenal aortic aneurysms with a wide infrarenal neck - HERCULES Trial
Rijnstate Ziekenhuis0 个研究点目标入组 28 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Age 18 years or older
- •Provided written informed consent
- •Clinical necessity for treatment of the AAA, according to the current
- •guidelines in the geographies participating
- •Elective repair
- •Eligible anatomy for treatment with the Endurant II/IIs endograft and Heli-FX
- •EndoAnchors according to the IFU of both devices
- •Infrarenal neck diameter >= 28 mm and <=32 mm
- •Proximal neck length >=10mm
排除标准
- •Anatomy outside the IFU of the Endurant II/IIs endograft and/or Heli-FX
- •EndoAnchors
- •Planned use of AUI main body device
- •Patient is participating in another clinical study, potentially conflicting
- •with the outcomes of the current study.
- •Patient with eGFR < 30 ml/min/1.73m2 before the intervention
- •Patient*s life expectancy <2 years as judged by the investigator
- •Patient has a psychiatric or other condition that may interfere with the study
- •Patient has a known allergy to any device component
- •Patients with a systemic infection who may be at increased risk of
- •endovascular graft infection.
- •Patient has a coagulopathy or uncontrolled bleeding disorder
- •Patient has a ruptured, leaking, or mycotic aneurysm
- •Patient is not eligible for standard EVAR
- •Patient had a Cerebro Vascular Accident (CVA) or a myocardial infarction (MI)
- •within the prior three months
- •Patient is pregnant (Female patients of childbearing potential only)
- •Patient has active COVID-19 infection or has been diagnosed with long
- •COVID-19 requiring hospitalization within the 6 months prior to procedure.
- •Patient has previously been treated with stent grafts in the aorto-iliac
研究者
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