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临床试验/NCT06680999
NCT06680999已完成不适用

Title Endovascular Treatment of Superior Cave Syndromes Reaching the Trifurcation: a Single-Center Case Series

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1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
20
试验地点
1
主要终点
Technical success, immediate clinical success

研究概览

简要总结

Superior vena cava syndrome (SCS) is caused by obstruction of blood flow in the superior vena cava, which allows venous return from the upper half of the body to the heart.

The causes are most often oncological, but can also be benign (coagulopathy, Behçet) or iatrogenic (catheterisation, PAC).

The surgical management of superior vena cava syndromes (SCS) involves the use of innovative endovascular techniques, which have become the therapy of first choice for symptomatic patients, whether the occlusion occurs in a benign or malignant context. For occlusive lesions involving the trifurcation, there are several surgical approaches and strategies, but very little data on their efficacy. In particular, Y-stenting has been described in several case reports as a means of treating the SCS and keeping the two jugulo-subclavian veins (VJSC) patent. This innovative technique has been used for several years by the vascular surgery team at Hôpital Louis Pradel.

The aim of our study is to assess the feasibility and medium-term efficacy of innovative endovascular treatments for SCS involving the trifurcation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients treated by endovascular surgery (stenting) at Hospices Civils de Lyon between March 2019 and July 2023 for superior cave syndrome

排除标准

  • Minor patients
  • Patients unable to give consent
  • Patients unable to understand French
  • Patients with lesions not reaching the trifurcation (elective involvement of the superior vena cava)

结局指标

主要结局

Technical success, immediate clinical success

时间窗: The primary endpoint will be evaluated by : - Technical success defined by patency postoperatively and at 1 month follow-up confirmed by phleboscanner. Assessment of patency after revascularisation will be based on CT scan data (if possible) or on the r

The primary endpoint will be evaluated by : - Technical success defined by patency postoperatively and at 1 month follow-up confirmed by phleboscanner. Assessment of patency after revascularisation will be based on CT scan data (if possible) or on the results of ultrasound data (letter from the angiologist) if this is the only test performed. Re-thrombosis of the inferior vena cava (IVC) or one of the two subclavian jugular veins (SCJV) will be sufficient to establish the absence of patency in our study. * Immediate clinical success defined by an improvement in symptoms observed by the medical team, and by a Yu score of less than or equal to 1 postoperatively and at 1 month follow-up.

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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