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临床试验/NCT04537052
NCT04537052Unknown不适用

A New Method for Treatment of Deep Venous Insufficiency: Early Results of Vein Restoration Treatment(VRT) Erdinç EROĞLU

Kahramanmaras Sutcu Imam University0 个研究点目标入组 24 人开始时间: 2020年9月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
24
主要终点
reflux times

研究概览

简要总结

To present the 9. months clinical results of percutaneous Ven Restoration Therapy (VRT), a new method in the treatment of primary femoral vein insufficiency.Twenty four patients diagnosed with isolated primary femoral vein insufficiency between January 2020 and December 2020 were included in the study. Before the procedure, junctional femoral vein diameters and reflux times were measured. CEAP classification and Venous clinical severity scores (VCSS) were recorded. Chronic Venous Insufficiency Questionnaire (CIVIQ-20) were also recorded. Then, VRT was applied percutaneously to the anterior and posterior of the femoral veins of the patients, and the diameter of the femoral vein was narrowed and valve coaptation was achieved. After the procedure, vein diameters and reflux times were measured again. All parameters were reevaluated by calling patients for control at 1.,3., 6. and 9. months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with isolated deep venous insufficiency, without accompanying superficial venous insufficiency,
  • volunteering to take part in the study were included

排除标准

  • post-thrombotic or congenital deep venous insufficiency
  • Venous reflux disease in the GSV diagnosed by clinical symptoms
  • Local or systemic infection

结局指标

主要结局

reflux times

时间窗: 9 months

reduce reflux times

femoral vein diameters

时间窗: 9 months

reduce femoral vein diameter

次要结局

未报告次要终点

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erdinç Eroğlu

Principal Investigator

Kahramanmaras Sutcu Imam University

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