Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 659
- 试验地点
- 21
- 主要终点
- Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion)
研究概览
简要总结
Cumulative radiation dose, cost, contrast induced nephrotoxicity and increased demand for computed tomography aortography (CTA) suggest that duplex ultrasonoraphy (DU) may be an alternative to CTA-based surveillance. The investigators compared CTA with DU during endovascular aneurysm repair (EVAR) follow-up.
Patients undergoing EVAR have radiological follow-up data entered in a prospectively multicenter database. The gold standard test for endoleak detection was CTA. DU interpretation was performed independently of CTA and vice versa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients who were followed after EVAR, whatever the trademark and the model of the stentgraft (bi-iliac or mono-iliac)
- •Age > 18 years old
- •Patient with social insurance
- •Signature of informed consent
排除标准
- •patients who underwent EVAR with a fenestrated or branched stentgraft
- •Obese patients (BMI > 30)
- •Patients with severe renal insufficiency (Creatinine Clearance < 30 ml/mn)
- •Patients who can't practice both an CT scan with iode injection and duplex ultrasound test over a period of one month
研究组 & 干预措施
Computed tomography scan versus color duplex ultrasound
干预措施: Computed tomography scan versus color duplex ultrasound (Procedure)
结局指标
主要结局
Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion)
时间窗: Between 1 week and 1 month
Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion) : * increasing aneurysm sac size (≥5mm), * type I or type III endoleak, * type II endoleak with an increasing aneurysm sac size (≥2mm) * significant stenosis of a limb of the stentgraft (≥70%).
次要结局
- All abnormalities, clinically significant or no(Between 1 week and 1 month)