Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.
Recruiting now · Phase 4
Conditions studied: Iliofemoral Venous Thrombosis
In brief
* 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.
Key facts
- Study ID
- NCT06472518
- Run by
- Nantes University Hospital
- People needed
- 228
- Starts
- 2026-05-20
- Expected to finish
- 2029-09-01
- Last updated by the study team
- 2026-05-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Dr Olivier Espitia — Nantes, France (enrolling)
Full record on ClinicalTrials.gov
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