Randomized Clinical Trial Comparing Surveillance and Selective Surgical Treatment for Abdominal Aortic Aneurysms Less Than 5.5 cm in Diameter Versus Early Endovascular Treatment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 360
- 试验地点
- 23
- 主要终点
- all cause mortality at 3 years
研究概览
简要总结
Objective of the present study is to compare endovascular repair versus surveillance and, eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with respect to patient survival, AAA rupture and AAA related death risks.
详细描述
The study will include patients with small AAA (diameter 4.1 to 5.4 cm defined by Computed Tomographic scan) suitable for endovascular repair (EVAR).
Randomization is designed with equal probability of assignment to each of the two groups (ie, immediate endovascular repair or surveillance group) by means of a computer-generated -random-number list . After eligibility is verified, assignment will be made using a computer database held at the Coordinating Centre.
In the immediate repair group, endovascular repair with introduction of an aortic endograft (Cook Zenith) will be performed within six weeks from randomization.
In the surveillance group, patients are followed without repair until the aneurysm reaches 5.5 cm in diameter, or enlarges at least 1.0 cm in one year, or until patient develops symptoms that are attributed to the aneurysm by the attending investigator. When one of these criteria is met, endovascular repair (if the patient remains a candidate for EVAR), or open repair will be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of 50-80 years of age
- •Non symptomatic infrarenal AAA of 4.1 to 5.4 cm in diameter measured by CT performed within 3 months before randomization
- •Adequate infrarenal aortic neck (length > 15 mm diameter < 30 mm) and other anatomical configurations suitable for EVAR
- •Patients have a life expectancy of at least 5 years
- •Signed informed consent
排除标准
- •Ruptured or symptomatic AAA
- •AAA maximum diameter >= 5.5 cm
- •Suprarenal or thoracic aorta aneurysm of more than 4.0 cm
- •Patient unsuitable for administration of contrast agent
- •Severe heart, lung, liver or renal disease (serum creatinine >= 3mg/dl)
- •Need for adjunctive major surgical or vascular procedures within 1 month
- •High likelihood of non compliance with follow-up requirements
研究组 & 干预措施
EVAR
AAA repair with endografting
干预措施: EVAR (Endovascular repair of Abdominal Aortic aneurysm) (Procedure)
Surveillance
Not AAA repair; surveillance
干预措施: Surveillance (Procedure)
结局指标
主要结局
all cause mortality at 3 years
时间窗: 3 years
次要结局
- risks associated with delayed treatment(30 days and 3 years)
- aneurysm rupture rates at 3 years(3 years)
- aneurysm growth rates(3 years)
- quality of life(30 days, 6 month, 1 year, 3 years)
- aneurysm related mortality at 3 years(3 years)
- conversion to open repair(30 days and 3 years)
- loss of treatment options(3 years)
- perioperative or late complications(30 days and 3 years)
研究者
Piergiorgio Cao, MD
Professor of Vascular Surgery
University Of Perugia