Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
试验速览
- 阶段
- 不适用
- 发起方
- UMC Utrecht
- 入组人数
- 392
- 主要终点
- combined operative mortality and morbidity
研究概览
简要总结
The purpose of this trial is to assess whether the new endovascular repair technique of the abdominal aortic aneurysm (AAA) is an adequate substitute of the conventional AAA repair.
详细描述
After the introduction of endovascular repair of abdominal aortic aneurysms (AAA), both benefits and drawbacks of this new technique have been reported. To assess whether the new technique is an adequate substitute of conventional AAA repair, a randomised study is required. The DREAM trial is a randomised multicenter trial enrolling patients eligible for elective treatment of infrarenal AAAs. The primary endpoint is combined operative mortality and morbidity. Secondary endpoints and additional assessments include event-free survival, quality of life,and costs.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asymptomatic, infrarenal AAA that requires surgery
- •Adequate infrarenal neck
- •Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the device to be used
- •Patient having a life expectation of at least 2 years and cleared for transabdominal intervention
- •Signed informed consent
排除标准
- •ruptured AAA or symptomatic AAA, which requires emergency surgery
- •maximum aneurysm diameter< 5.0 cm
- •suprarenal AAA
- •Inflammatory AAA (more than minimal wall thickening)
- •infrarenal neck unsuitable for endovascular fixation or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used
- •bilateral retroperitoneal incision required for EVAR
- •sacrifice of both hypogastric arteries required
- •anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation
- •patient unsuitable for laparotomy
- •administration of contrast agent not possible: proved, severe systemic reaction to contrast agent
- •active infection present
- •transplantation-patients
- •limited life expectation due to other illness (< 2 year)
- •non-iatrogenic bleeding diathesis
- •connective tissue disease
结局指标
主要结局
combined operative mortality and morbidity
时间窗: 5-8 years
次要结局
- event free survival(5-8 years)
- quality of life(5-8 years)
- cost-effectiveness(5-8 years)