Clinical trial NCT06472518: Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Iliofemoral Venous Thrombosis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients with acute iliofemoral thrombosis will be included in the study after consent. They will be randomized to pharmaco-mechanical thrombolysis combined with anticoagulant therapy with direct oral anticoagulant versus direct anticoagulant therapy alone. They will be monitored, and patients in the anticoagulation-only group may undergo stenting angioplasty in the chronic phase if they present a moderate post-thrombotic syndrome or venous claudication. At the end of 30 months, a medico-economic analysis will be carried out.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Cost-utility analysis
timeFrame: 30 month
Secondary outcomes:
measure: Number of patients with Villalta score greater than or equal to 10
timeFrame: 30 month
measure: Number of patients with Villalta score greater than or equal to 15, or presence of ulceration
timeFrame: 30 month
measure: Number of major hemorrhages and number of clinically relevant non-major hemorrhages according to ISTH criteria
timeFrame: 1, 30 and 60 month
measure: Number of patients with pain greater than or equal to 7 as assessed by the visual analog scale, or the presence of venous claudication, or lower-limb edema with a circumference greater than 20% of the contralateral leg, or failure to return to work.
timeFrame: 1 month
measure: VEIN-QOL
timeFrame: 1,30 and 60 month
measure: CIVIQ 20
timeFrame: 1,30 and 60 month
measure: SF36 scores
timeFrame: 1,30 and 60 month
measure: Number of patients with onset of venous claudication
timeFrame: 30 month
measure: Number of patients with a trophic disorder, assessed by clinical examination
timeFrame: 60 month
measure: Incremental cost-utility ratio of MPT compared with anticoagulation strategy
timeFrame: 60 month
measure: Net financial impact over 5 years of TPM distribution
timeFrame: 60 month
Other outcomes:
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