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临床试验/NCT02959801
NCT02959801Unknown4 期

Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis

Beijing Tsinghua Chang Gung Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
4 期
入组人数
50
试验地点
1
主要终点
post-thrombotic syndrome

研究概览

简要总结

The purpose of this study was to compare the efficacy of Percutaneous mechanical thrombectomy (PMT) followed by standard anticoagulant therapy, with anticoagulation therapy alone, for the treatment of acute proximal lower extremity deep vein thrombosis.

详细描述

The conventional treatment of acute deep vein thrombosis (DVT) is anticoagulation therapy, as recommended in the international guidelines. Anticoagulation prevents recurrent venous thrombosis, pulmonary embolism, and death. Early thrombus removal is now considered as the standard of medical care for deep vein thrombosis (DVT). Early thrombus removal can offer the potential for early restoration of venous patency and preservation of valve function. Percutaneous mechanical thrombectomy (PMT) uses a number of catheter-based mechanical devices to deliver the thrombolytic agent as well as to produce some combination of thrombus fragmentation, distribution of thrombolytic drugs throughout the thrombus, and/or thrombus aspiration. The purpose of this study was to compare the efficacy of Percutaneous mechanical thrombectomy (PMT) followed by standard anticoagulant therapy, with anticoagulation therapy alone, for the treatment of acute proximal lower extremity deep vein thrombosis.

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 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • proven acute deep venous thrombosis, less than 21 days and who were referred to the interventional radiology department.

排除标准

  • presence of subacute or chronic DVT more than 21 days in duration, inability to lie in the prone position required for intervention, terminal systemic disease requiring palliative treatment, active bleeding (from a gastric/duodenal ulcer or the cerebrovascular system), a haemorrhagic stroke within the previous year, an impaired bleeding-clotting profile, and any haemophilic disorder, or pregnancy.

结局指标

主要结局

post-thrombotic syndrome

时间窗: one year

Clinical scoring was used to compare clinical symptoms and patient findings between the groups at six month and one year after treatment.

次要结局

  • complication(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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