NCT03026049终止不适用
A Randomized Controlled Trial Comparing Venous Stenting With Conservative Treatment in Patients With Deep Venous Obstruction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Quality of Life score
研究概览
简要总结
Patients will be randomised between deep venous stenting or conservative management
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
- Single (Outcomes Assessor)
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
- •Age >18 years
- •Meet criteria for PTS or
- •Patients with May Thurner syndrome on additional imaging
- •Life expectancy of more than one year
- •Deep venous thrombosis > 1 year
- •Signed informed consent
排除标准
- •Previous intervention of central veins (inferior vena cava, iliac veins, common femoral vein) on the affected limb
- •Known pregnancy
- •Inability to answer Dutch QoL questionnaires or limited communication in Dutch (written and spoken)
- •Contra-indication for prolonged anticoagulant treatment
- •Recent, <1 year, deep venous thrombosis or pulmonary Embolism
- •Known contrast allergy
- •Known dialysis or renal insufficiency needing additional preparation for injection of contrast
研究组 & 干预措施
conservative managment
No Intervention
Conservative management of complaints
deep venous stent
Active Comparator
Patients will receive deep venous stenting in the iliaco(femoral) region
干预措施: deep venous stenting (Device)
结局指标
主要结局
Quality of Life score
时间窗: 12 months
Quality of Life score
次要结局
未报告次要终点
研究者
研究点 (1)
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