Post-registration Observational Study on the Custom-made Abdominal Aortic Endograft Fenestrated Anaconda™
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 106
- 试验地点
- 33
- 主要终点
- Long-term outcome of use of Fenestrated Anaconda
研究概览
简要总结
The French Ministry registered the Fenestrated Anaconda ™ on the List of Reimbursable Products and Services (LPPR) by the French Health Insurance on February 2018 for a duration of 5 years, while taking up the conditions for carrying out the act recommended by the CNEDiMTS (Committee in charge of medical device review), namely the carrying out of a post-registration study for the renewal of the authorization. This renewal of registration is conditioned by the set-up of a long-term follow-up study of all patients treated with the Fenestrated Anaconda ™ in France.
To do this, this study will be carried out in partnership with the Federation of Medical Specialties (FSM) and the National Professional Council (CNP) of Vascular Surgery in order to have the data necessary for the renewal of the registration of the Fenestrated Anaconda ™ from the registry called Datavasc developed by the CNP and available online on the FSM's electronic platform.
详细描述
EPI-EFA study: Post-registration study of the Fenestrated Anaconda™ in the management of a complex abdominal, juxtarenal, pararenal, suprarenal aortic aneurysm, whether or not associated with a distal common iliac artery or thoracoabdominal aneurysm type IV, in high-risk patients requiring treatment, for whom a surgical contraindication has been asked.
- Study type : observational, national, multi-centre, prospective, non-comparative study, as open registry
- Primary objective : To evaluate the long-term interest of Fenestrated Anaconda™ on all patients treated with in France. The data collected should be:
- 1-year mortality rate related to device, procedure, any cause = primary endpoint
- Stent-related adverse events (endoleak, migration, integrity of the device), renal events, ischemia (medullary (paraplegia / paraparesis), intestinal) = secondary endpoints
- Study timelines :
- Duration / follow-up :
- 1-year recruitment period from October 2019, with a minimum of 91 patients
- Mid-term follow-up : at 1 year
- Routine practice : until 5 years
- Reports to be submitted to French Health Authority :
- Interim report with mid-term follow-up data for renewal dossier
- Final report with long-term follow-up data
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Long-term outcome of use of Fenestrated Anaconda
时间窗: 1 year
Device-related mortality, procedure-related mortality, all-cause mortality
次要结局
- Stent-related adverse events(5 years)
- Renal adverse events(5 years)
- Ischemia(5 years)