Technical success and outcomes using novel Banode-Mishra Technique (BMT) versus endovascular Rotational Thrombectomy device in acute iliofemoral vein thrombolysis
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
Dr Vadlamudi Nagendra
Datta Meghe Institute of Medical sciences, Wardha
