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临床试验/NCT06451484
NCT06451484已完成不适用

Multicenter Study to Evaluate a Severity Score Using Venous MRI and CT in Patients With Post-Phlebitic Syndrome

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Grade of vein severity on phleboscanner

研究概览

简要总结

The aim is to improve the diagnosis of chronic lower limb venous thrombosis before a lower limb venous recanalization procedure. Additionally, if the MRI scores are comparable to those of the CT, MRI would reduce radiation exposure and limit the need for foot vein punctures that accompany CT use.

详细描述

Endovascular management of post-thrombotic syndrome (PTS) has created new opportunities for patients and interventional radiologists. PTS is the most chronic complication of deep vein thrombosis (DVT), occurring in 20% to 40% of patients despite optimal anticoagulant therapy within the first 1 to 2 years after a lower limb DVT. PTS is characterized by various symptoms lasting more than 6 months after a DVT, including mild pain or swelling, venous claudication, heaviness/fatigue, chronic pain or cramps, venous ulcers, edema, skin discoloration, and venous ectasia. Severe PTS negatively impacts quality of life. Several clinical tools or scales, such as the Villalta scale and CIVIQ-20, are used to diagnose and define PTS. Endovascular treatment of symptomatic chronic iliofemoral vein occlusions has shown good technical and clinical efficacy, with significant clinical benefits and improvements in the Villalta and CIVIQ scores. Proper planning of the recanalization procedure is essential, using CT and MRI imaging to analyze the venous anatomy in the pelvis, abdomen, and lower limbs. The CT is the reference examination for chronic lower limb thrombosis, performed using the Baldt technique to opacify the deep venous network and detect endoluminal adhesions. However, there are risks such as failure to puncture the veins on the back of the foot, pain during puncture, and flow artifacts. MRI is less commonly used due to its availability and long examination times, but its results are promising. The literature on chronic lower limb thrombosis is limited, with no consensus on lesion descriptions, highlighting the need for a descriptive lesion score

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

  • Men and women aged more than 18 years old,
  • patient's oral consent,
  • affiliated or beneficiary of health insurance

排除标准

  • inability of the patient to understand the nature or risks or significance and implications of the clinical investigation,
  • patient under legal protection

结局指标

主要结局

Grade of vein severity on phleboscanner

时间窗: Baseline

Grade of vein severity on phleboscanner (from A-normal to D-very severe)

次要结局

  • Grade of vein severity on MRI(Baseline)
  • Inter-observator reproducibility on MRI(Baseline)
  • Inter-observator reproducibility on phleboscan(Baseline)
  • Reproducibility between MRI and phleboscan(Baseline)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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