Long-term Effect of Different Modes of Endovascular Therapy in Combination With Anticoagulation Treatment in Patients With Acute Extensive Deep Vein Thrombosis (LEVANTE Research)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Post-thrombotic syndrome
研究概览
简要总结
Despite optimal anticoagulation therapy of patients with proximal deep vein thrombosis (DVT), there is still high number of patients suffering from post-thrombotic syndrome (PTS) due to the chronic venous occlusion, suboptimal collateralization, and venous valvular dysfunction. Last two decades endovascular catheter-based treatment modalities have been tested and used in an attempt to reduce incidence and symptoms of PTS in selected patients.
Especially, patients with extensive iliofemoral DVT have an increased risk of PTS. In an effort to accelerate thrombus dissolution or thrombus extraction, the endovascular removal of acute venous thrombus has been introduced as therapeutic option in patients with extensive iliofemoral DVT.
Randomized trials of catheter-based strategies for thrombus removal have documented improved vein patency, preserved valves function, and reduced post-thrombotic syndrome.
The aim of our study is to evaluate the safety and efficacy of different types of endovascular methods of treatment followed by anticoagulation therapy in patients with acute extensive DVT. Retrospective multicentre analysis of app 100 patients scheduled for endovascular treatment of extensive DVT. The results of mechanical/pharmacomechanical thrombectomy followed by local catheter directed thrombolysis (CDT), will be compared with CDT alone, or with ultrasound-accelerated thrombolysis. The 24-month incidence of PTS assessed by Villalta scoring system, major bleeding complications, the rate of venous recanalization, recurrence of DVT, and other end-points will be evaluated.
详细描述
Aim: The aim of the study is to evaluate the long-term incidence of PTS in patients treated by different endovascular methods and protocols in combination with anticoagulation medication in patients with acute extensive DVT.
Hypothesis: Mechanical / pharmacomechanical thrombectomy (PMT) following by CDT and further anticoagulation therapy is safe and effective mode of acute DVT treatment with reduction of PTS after 24 months in comparison with historical data and with other modes of endovascular therapy.
Methods: Retrospective multicentre analysis of patients scheduled to interventional endovenous treatment of extensive DVT.
The major end-point:
- The development of PTS during the 24-month follow-up period
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •first episode of acute iliofemoral DVT
- •duration of symptoms <14 days
- •symptomatic patients with no or limited response to initial anticoagulation therapy in terms of symptomatology and signs of recanalization
- •low bleeding risk
- •good functional capacity and life expectancy
排除标准
- •- presence of malignity (2 centers out of 3)
- •pregnancy
- •haemorrhagic diathesis / high risk of bleeding
- •negative prognosis of survival
- •renal / hepatic failure
- •chronic course of DVT
结局指标
主要结局
Post-thrombotic syndrome
时间窗: 24-month follow-up period
The occurrence of PTS will be assessed by clinical evaluation and by Villalta scoring system (0-33), higher scores mean a worse outcome.
次要结局
- The rate of venous recanalization after intervention(early - in-hospital (up to day 7), 6-month)
- The development of PTS during the 6-month and 12-month follow-up period(6-month and 12-month follow-up period)
- Mortality, MI, stroke during follow-up(In-hospital (up to day 7), 12-month, 24-month follow-up)
- The occurrence of pulmonary embolism(early - in-hospital (up to day 7), 12-month, 24-month follow-up)
- Recurrence of DVT(12-month, 24-month follow-up)
- The occurrence of major bleeding and live-threatening bleeding episodes(periprocedural, in-hospital (up to day 7), 24 months)
研究者
Juraj Maďarič, MD
assoc. prof. Juraj Maďarič, PhD., MPH, Department of Cardiology and Angiology - head of the unit
National Institute of Cardiovascular Diseases, Slovakia