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临床试验/NCT05827120
NCT05827120已完成不适用

Long-term Effect of Different Modes of Endovascular Therapy in Combination With Anticoagulation Treatment in Patients With Acute Extensive Deep Vein Thrombosis (LEVANTE Research)

National Institute of Cardiovascular Diseases, Slovakia3 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年3月23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
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:

  1. 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

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

发起方
National Institute of Cardiovascular Diseases, Slovakia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juraj Maďarič, MD

assoc. prof. Juraj Maďarič, PhD., MPH, Department of Cardiology and Angiology - head of the unit

National Institute of Cardiovascular Diseases, Slovakia

研究点 (3)

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