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临床试验/NCT05954663
NCT05954663已完成不适用

Clinical and Hemodynamic Evaluation After Venous Recanalization of Post-thrombotic Iliofemoral Syndromes

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年11月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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