Endurant Stent Graft Natural Selection Global Postmarket Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,266
- 试验地点
- 80
- 主要终点
- Treatment Success
研究概览
简要总结
The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.
详细描述
The Endurant Stent Graft Natural Selection Global Post-market Registry, ENGAGE is initiated to expand the clinical knowledge base by including 'real world' subjects, applying a minimal amount of subject selection criteria. This subject group may better represent the subject profile treated in actual clinical practice without selecting sub-groups of particular low/high risk or excluding certain diseases. ENGAGE aims at following and documenting the subject selections, diagnostic tools used and treatment interventions chosen by the vascular surgeon or interventional radiologist. ENGAGE will not impose CIP required study procedures affecting clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years or minimum age as required by local regulations
- •Indication for elective surgical repair of AAA with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System
- •Signed consent form ("Patient informed consent Form" or "Patient Data Release Authorization Form"). The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information
- •Intention to electively implant the ENDURANT Stent Graft System
- •Ability and willingness to comply with the CIP.
排除标准
- •High probability of non-adherence to physician's follow-up requirements
- •Current participation in a concurrent trial which may confound study results
结局指标
主要结局
Treatment Success
时间窗: 10 years
次要结局
- Stent Graft Endoleaks(10 years)
- Aneurysm-related mortality(10 years)
- AAA Diameter Increase(10 years)
- Technical Observations(5 years)
- All-cause mortality(10 years)
- MAE(30 days)
- Adverse Device Effects(10 years)
- Health Related Quality of Life Scores(12 months)
- Stent Graft Migration(10 years)
- Stent Graft Patency(10 years)
- Secondary procedures to correct Type I and III endoleaks(10 years)
- Secondary endovascular procedure(10 years)
- Stent Graft Stenosis(10 years)