Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.
Prospective Randomised Multicentre Medico-economic Evaluation of Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.
Nantes University Hospital
228 participants
May 20, 2026
INTERVENTIONAL
Conditions
Summary
* Iliofemoral DVTs (IF DVTs) are vascular disorders associated with high morbidity and mortality, which can be complicated by long-term post-thrombotic syndrome (PTS). * Pharmaco mechanical thrombolysis (PMT) is an innovative endovascular technique involving in situ fibrinolysis of the thrombus in the acute phase of thrombosis, followed by mechanical extraction by fragmenting the thrombus. * The American ATTRACT study showed that management by catheter-directed thrombolysis and/or PMT in the acute phase is safe and effective at 2 years in a subgroup of DVTif compared with anticoagulation (18% moderate or severe SPT with thrombolysis vs. 28% without thrombolysis). * PMT-DVT will be the first study to assess the medium (30 months) and long-term (60 months) efficacy of PMT in the French context, using data from the French National Health Data System.
Eligibility
Inclusion Criteria8
- Patients who agreed to participate in the study and gave oral consent.
- Patient affiliated to a social security scheme
- Iliac and/or common femoral venous thrombosis
- Recent thrombosis less than or equal to 14 days since qualifying imaging or less than or equal to 21 days since onset of symptoms
- And at least 1 of the following criteria:
- Visual analog scale greater than or equal to 5 and/or
- Venous claudication and/or
- Increase in thigh circumference greater than or equal to 5% compared with contralateral thigh.
Exclusion Criteria6
- Patients with superficial femoral or popliteal venous thrombosis without involvement of the common femoral or iliac veins.
- Patients with isolated thrombosis of the inferior vena cava, without extension to the iliac veins.
- Thrombosis of inferior vena cava proximal to the renal veins.
- Minors, pregnant women, adults under guardianship.
- Chronic renal failure with creatinine clearance below 30ml/min according to Cockroft.
- Ischaemic phlebitis: proximal venous thrombosis associated with limb ischemia and impaired arterial flow.
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Interventions
arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants
Locations(1)
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NCT06472518