DUTCH CAVA-trial: CAtheter Versus Anticoagulation Alone for Acute Primary (Ilio)Femoral DVT.
Condition: Acute Thrombosis of Deep Veins of Proximal Lower Extremity
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Rationale: Iliofemoral deep venous thrombosis (IFDVT) is associated with significant post
      thrombotic morbidity. The presence of both obstruction and reflux significantly increases the
      chances for development of post-thrombotic syndrome (PTS). Early thrombolysis may reduce the
      incidence of PTS as compared to treatment with conventional anticoagulant medication alone.
      Improvement of the health related quality of life (HRQOL) has been reported after surgical
      clot removal. The investigators hypothesize that such improvements could also be reached
      after catheter-directed thrombolysis (CDT).

      Objective: To assess whether CDT for the treatment of IFDVT can safely and effectively reduce
      post-thrombotic morbidity after one year. The secondary objective is to study whether CDT
      intervention has a positive effect on the HRQOL of patients with IFDVT and to assess late
      PTS.

      Study design: Prospective, multicenter, single-blind, allocation concealed, randomized
      controlled trial Study population: All consecutive patients with IFDVT presenting at the
      emergency or outpatient departments of the participating centers. The thrombus should not be
      older than 14 days at randomization.

      Intervention: After randomization patients will be allocated to either conservative
      anticoagulant treatment or to CDT combined with conservative anticoagulant treatment.

      Main study parameters/endpoints: The primary efficacy outcome is the proportion of PTS at one
      year; a decline in PTS incidence from 25% to 8% is anticipated. The secondary outcome is the
      Health related Quality of life. The principal safety outcome is major bleeding during
      anticoagulant therapy. Bleeding as well as events of recurrent thrombosis will be monitored.
      Measurements of markers of coagulation and inflammation will be performed during follow-up.
      After CDT the patency of the venous system in the affected lower limb will be assessed as
      well as the percentage of clot lysis. The development of late PTS during follow-up will also
      be monitored.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: For patients who are randomized to CDT a hospital stay for 24-96 hours is
      mandatory. All patients will undergo additional imaging by magnetic resonance venography and
      air phletysmography (if available) at baseline and after 12 months; blood will be taken at
      these visits. Clinical follow-up visits will be matching usual care at 3, 6, 12 months.
      Health-related quality of life (HRQOL) questionnaires will be filled out by all patients at
      baseline, 3, 6 and 12 months after the event; and once a year during the entire study
      duration. Further treatment will be in accordance with current guidelines for antithrombotic
      treatment. There may be an enhanced risk of bleeding in the thrombolysis group. The expected
      benefit is reduction of PTS from 25% to 8%, together with an improved quality of life.
    


Intervention name(s): Ekos endowave system thrombolysis
Intervention type(s): Device
Intervention description(s): Catheter directed thrombolysis will be performed with an Ekos Endowave ® system (EKOS Corporation, Bothell, WA). The system uses a standard guide wire to position the Intelligent Drug Delivery Catheter across the length of the target clot. The guide wire is introduced through the popliteal vein. Along the guide wire the catheter is positioned. The location of the dispersion catheter is controlled and if necessary adjusted by X-ray. The guide wire is then pulled out and replaced with the Microsonic core (a miniscule high frequency (2MHz) ultrasound transducer). The system automatically monitors and controls the microsonic energy delivery. This system does not fragment the thrombus but only gives a structural change by which a better penetration of the thrombolytic agent is achieved.
Other intervention name(s): Ekos endowave ® system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment