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临床试验/NCT05662761
NCT05662761招募中不适用

Assessment of the Relationship Between Severity of Chronic Venous Obstruction and Venous Claudication

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
pain -free walking distance

研究概览

简要总结

Assessment of the Relationship between Severity of Chronic Venous Obstruction and Venous Claudication

详细描述

The postthrombotic syndrome (PTS) occurs in about 20-50% of patients after a deep Venous thrombosis and significantly affects the quality of life of patients. With the patency rates of 73-100% are achieved with endovascular procedures. At 58% of patient ulcer healing was achieved. Neglen et al. could a significant demonstrate an improvement in quality of life. Aim of the study: To show the influence of the increased inflow to venous Objectively review recanalization for patient symptoms and walking performance. Therefore, before and after venous interventions, to assess walking performance and pain-free Measure the walking distance of the patient on the treadmill and compare it to get a possible identifying relevant and/or significant changes.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with an obstruction in the femoral vein communis, V. iliaca externa, V. iliaca communis or V. cava inferior
  • Age: 18-80 years old
  • Signed informed consent form
  • Persons who are legally competent and mentally capable, to follow the instructions of the staff

排除标准

  • Patients under 18 years of age.
  • Patients who are unable to consent and/or not in are able to appreciate the nature, importance and scope of the study understand and give their consent in writing.
  • Persons acting by administrative or judicial order are housed in a facility
  • Patients who abuse drugs
  • Peripheral arterial disease stage IIb, III and IV -

结局指标

主要结局

pain -free walking distance

时间窗: 2022-2025

pain-free walking distance after venous recanalization and stent implantation

次要结局

  • 2(2022-2025)
  • Stent openness rate(2022-2025)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Houman Jalaie

Deputy Head of the Department of Vascular & Endovascular Surgery of the University Hospital of AachenPD Dr. med Houman Jalaie

RWTH Aachen University

研究点 (1)

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