Clinical and Hemodynamic Evaluation After Venous Recanalization of Post-thrombotic Iliofemoral Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Clinical improvement
研究概览
简要总结
Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT). The endovascular recanalization and stenting technique has become the gold standard treatment for medically resistant and disabling PTS.
Stent thrombosis is a significant complication of this procedure; the risk factors for thrombosis are poorly understood.
Monitoring the patency of the stent is a key component in maintaining clinical success.
Doppler ultrasound is the first-line diagnostic tool for monitoring patients with venous stents, and has the potential to allow accurate assessment of venous stent obstruction.
Absence of validated morphological and hemodynamic echodoppler criteria for the follow-up of these stents.
• Main objective: Clinical and hemodynamic results of venous recanalisations by stenting in the chronic phase
• Secondary objective (s):
- External validation of hemodynamic criteria proposed in the literature to detect venous stent obstruction
- Risk factors for venous stent restenosis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 67 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disabling post-thrombotic syndrome (venous claudication) after at least 6 months of proximal deep vein thrombosis.
排除标准
- •Inability to consent
- •Age <18 years old
- •Life expectancy <3 months
- •Incomplete medical records
- •Lost in follow up
结局指标
主要结局
Clinical improvement
时间窗: 6 first month post intervention
Villalta score * Score ≤ 4: No TPS. * Score between 5 and 14: mild TPS. * Score between 10-14: moderate TPS. * Score ≥ 15 or ulcer present: severe TPS.
Stent patency
时间窗: 6 first month post intervention
Analyze of venous patency of each venous segment Maximum peak flow velocity (in centimetres per second) at each venous segment Location of the implanted stents Cranial and caudal extremity Total length Diameter
次要结局
未报告次要终点
