Ultrasound-enhanced Thrombolysis Versus Standard Catheter Directed Thrombolysis for Ilio-femoral Deep Vein Thrombosis
Condition: Venous Thrombosis; Postthrombotic Syndrome
MeSH terms: Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome
Study type: Interventional

Summary: 
      Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for
      developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to
      more distal DVT. There's evidence that the early removal of the obstructing thrombus by
      catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher
      degree of thrombolysis is associated with lower incidence of PTS, better quality of life and
      lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced
      thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency,
      low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic drugs
      accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis, however
      the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been formally
      assessed in vivo. The hypothesis for this study is that ultrasound-enhanced thrombolysis
      reaches a higher degree of thrombolysis than standard CDT in patients with symptomatic
      ilio-femoral DVT.
    

Detailed description: 
      Background

      Deep vein thrombosis (DVT) is a public health problem with an annual incidence of 1 per 1000.
      Besides the acute risk of potentially fatal pulmonary embolism or phlegmasia cerulea dolens,
      these patients are at increased risk of recurrent venous thromboembolism, and in the long
      term 20-40% of them develop a post-thrombotic syndrome (PTS). PTS mainly develops in patients
      with DVT affecting the ilio-femoral veins, adversely affects the quality of life and causes
      important health care costs to the society. There's evidence that the early removal of the
      obstructing thrombus reduces the risk of developing a PTS, and a higher degree of
      thrombolysis is associated with lower incidence of PTS, better quality of life and lower risk
      of recurrent venous thromboembolism. Therefore, in addition to standard anticoagulation
      therapy, the latest international guidelines recommend catheter-directed thrombolysis (CDT)
      as first-line treatment for patients with ilio-femoral DVT and low bleeding risk. CDT refers
      to the infusion of thrombolytic drugs directly into the thrombus via a multisidehole catheter
      which is embedded in the thrombus using imaging guidance. A further development is
      ultrasound-enhanced thrombolysis combining CDT with a sophisticated catheter system that
      employs high-frequency, low-dose ultrasound. In vitro experiments showed that adding
      Ultrasound to thrombolytic drugs accelerates thrombolysis while Ultrasound exposure alone
      results in no thrombolysis. Although ultrasound-enhanced thrombolysis is now widely used to
      treat ilio-femoral DVT or high-risk pulmonary embolism, it is currently not known if this
      technique is superior to standard CDT.

      Objective

      To determine if the addition of intravascular high-frequency/low-dose ultrasound to standard
      CDT increases the percentage of clot lysis compared to CDT alone after treatment duration of
      15 hours in patients with symptomatic ilio-femoral DVT and low bleeding risk

      Methods

      Study design: open-label (with blinding of data-analyzing physicians), randomized,
      controlled, single center clinical trial with a follow-up period of 12 months.

      Subjects: total of 20 patients (10 in each study group) of 18-75 years of age with acute,
      symptomatic, objectively confirmed ilio-femoral DVT and a low bleeding risk.

      Intervention: CDT using the EkoSonic Endovascular System with (CDT+US group) or without
      (CDT-US group) intravascular high-frequency, low-power ultrasound for 15 hours.
    

Intervention name(s): CDT+US group; CDT-US group
Intervention type(s): Procedure; Procedure
Intervention description(s): CDT using the EkoSonic Endovascular System with intravascular high-frequency, low-power ultrasound for 15 hours.; CDT using the EkoSonic Endovascular System without intravascular high-frequency, low-power ultrasound for 15 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: catheter-directed thrombolysis; ilio-femoral deep vein thrombosis; Postthrombotic syndrome; Phlebographic scores; Phlebography; Catheters