ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis "
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Death and major adverse events
研究概览
简要总结
Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.
The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.
详细描述
ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.
The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients aged 50 years old or more (more than 80 possible depending on physiological age)
- •Level 0, 1, or 2 of operative risk
- •Abdominal aortic aneurysm with a diameter > or equal to 50 mm or > or equal to 40 mm if rapid growing (10 mm or more in a year), or painful, or saccular aneurysms, or aneurisms of common iliac arteries with a diameter equal or superior to 30 mm; or women with a diameter equal to 45 mm;
- •Aortic neck superior or equal to 1.5 cm
- •No stenosis superior or equal to 75% of the superior mesenteric artery
- •Proximal neck angulation inferior to 80°
- •Diameter of the iliac arteries compatible with introducer sheath
- •Inform consent signed
排除标准
- •Aneurysm involving the renal arteries or with the length of the neck less than 1.5 cm
- •Thrombus or major calcification in the neck
- •Diameter of the iliac arteries not compatible with introducer sheath
- •Level 3 of operative risk
- •History of major iodine allergy (Quincke oedema, anaphylactic shock)
- •Other comorbidity with life expectancy less than 6 months
- •Follow up impossible during the trial
- •Participation in another trial
- •Inform consent not signed
结局指标
主要结局
Death and major adverse events
时间窗: 4 years
次要结局
- Minor adverse events (systemic vascular or non vascular complications)(4 years)