跳至主要内容
临床试验/CTRI/2024/04/066001
CTRI/2024/04/066001已完成Phase 3 4

Technical success and outcomes using novel Banode-Mishra Technique (BMT) versus endovascular Rotational Thrombectomy device in acute iliofemoral vein thrombolysis

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年7月16日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
efficacy of BMT over cleaner XT device.

研究概览

简要总结

Deep venous thrombosis (DVT) is a major public health problem resulting in significant morbidity and mortality, having 0.1% per year incidence in the adult population. Standard treatment includes medical anticoagulant therapy or pharmacomechanical catheter-directed thrombolysis. Despite the use of anticoagulant therapy, ATTRACT trial demonstrated that post thrombotic syndrome develops over two years in approximately 50% of patients with lower extremity DVT. At our hospital, we have used Banode Mishra technique© as a novel approach in the treatment of iliofemoral vein thrombolysis and compared the findings with another group of patients who were treated with Cleaner 15TM rotational thrombectomy device. A randomized control interventional study will be conducted and carried out in patients with acute iliofemoral DVT requiring thrombolysis and admitted in department of interventional radiology, AVBRH, Datta Meghe Institute of Higher Education and Research.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients with primary acute iliofemoral DVT.

排除标准

  • Patient unable to provide informed consent Sepsis or active infection Recent intracranial bleed or gastrointestinal bleed within the past three months Allergy to iodinated contrast media, antiplatelet drugs, heparin Pregnancy Life expectancy less than 12 months based on physicians estimate.

结局指标

主要结局

efficacy of BMT over cleaner XT device.

时间窗: Six months

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Vadlamudi Nagendra

Datta Meghe Institute of Medical sciences, Wardha

研究点 (1)

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