Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
研究概览
简要总结
The aim of this project is to demonstrate the benefit of the use of aortic iliac branch endoprosthesis in the iliac aneurysms and to avoid the classic complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High surgical risk:
- •Comorbidity cardiopulmonary
- •Renal insufficiency
- •Hostile abdomen including ascites or portal hypertension
- •Anatomic criteria:
- •Primitive iliac aneurysm superior to 25 mm without collar
- •Primitive iliac length superior to 40 mm
- •Primitive iliac distal diameter superior to 14 mm
- •Presence of internal iliac collar
- •Affiliation to a social security system
排除标准
- •Patient without surgical risk
- •Non-respect of the Anatomic criteria
- •Patient with known allergy to the materials of the device
- •Patient with systemic infection
- •Patient with severe renal insufficiency
- •Patient unable to complete the oximetry test
- •Persons under legal protection
结局指标
主要结局
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
时间窗: at 12 months after surgery
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion. It is a binary criterion (permeable or not) This criterion will be evaluated by a doppler ultrasound. These exams will be performed by a unique vascular physician, who will measure the hemodynamic criterions and the associated gluteal region oximetry. Endoprosthesis will be considered to be permeable if the patient is asymptomatic (absence of gluteal claudication), if Doppler ultrasound and angio-scan confirm the permeability of the endoprosthesis. Primary permeability will be considered non-maintained at 1 year if a stenosis \>70% or a thrombosis of the hypogastric branch is observed by ultra-sound scan at a follow-up visit during the first year after surgery or at a ultra-sound scan exam motivated by pelvic ischemia clinical signs
次要结局
- Morbidity(peri-operative, at short term (3 months), mean-term (12 months))