NCT03309969Unknown不适用
Comparison of Intravascular Ultrasound With Venography in the Diagnosis and Treatment of Iliac Vein Compression Syndrome
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年10月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage diameter reduction
研究概览
简要总结
The aim of this study is to compare intravascular ultrasound with venography in the diagnosis and treatment of iliac vein compression syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 90 years
- •Willing to participate in and sign the informed consent
- •Patients with suspicious iliac vein stenosis or compression presented by preoperative magnetic resonance venography (MRV)
- •Patent common femoral vein and/or femoral vein of the study leg
- •Undergoing iliofemoral venography with the intend to treat potential iliac vein compression syndrome
排除标准
- •Not providing informed consent
- •Venous compression caused by pelvic tumors or fibroid uterus
- •Previous stent implantation or venovenous bypass surgery of the study leg
- •Known metal allergy precluding the possibility of stent implantation
- •Known iodine allergy or severe renal insufficient function which are unsuitable for venography
- •Pregnant or planning to be pregnant recently
- •Acute deep vein thrombosis or tumor thrombus involving the study leg
- •Know history of thrombophilia (e.g. protein C or S deficiency, anti-thrombin III deficiency, etc )
- •Any concurrent disease, for example, heart failure, might make the patients unsuitable for surgery
结局指标
主要结局
Percentage diameter reduction
时间窗: 1 month
Compare the percentage diameter reduction measured by intravascular ultrasound (IVUS) and venography
Percentage area reduction
时间窗: 1 month
Compare the percentage area reduction measured by IVUS and the calculated percentage area reduction measured by venography
次要结局
- CEAP score(18 months)
- Secondary patency(18 months)
- Primary patency(18 months)
研究者
研究点 (1)
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