Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.

Phase 4Not Yet RecruitingNCT06472518

Nantes University Hospital228 enrolled

Overview

* 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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

228

Conditions

Iliofemoral Venous Thrombosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Cost-utility analysis

Cost-utility analysis of the economic efficiency of the PMT strategy compared with the anticoagulation strategy for the treatment of DVT from a collective perspective and a 30-month time horizon

Time frame: 30 month

Secondary Outcomes

Number of patients with Villalta score greater than or equal to 10

Time frame: 30 month

Number of patients with Villalta score greater than or equal to 15, or presence of ulceration

Time frame: 30 month

Number of major hemorrhages and number of clinically relevant non-major hemorrhages according to ISTH criteria

Time frame: 1, 30 and 60 month

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.

Time frame: 1 month

VEIN-QOL

overall assessment by questionnaire

Time frame: 1,30 and 60 month

CIVIQ 20

score 0 to 100

Time frame: 1,30 and 60 month

SF36 scores

score 0 to 100

Time frame: 1,30 and 60 month

Number of patients with onset of venous claudication

Time frame: 30 month

Number of patients with a trophic disorder, assessed by clinical examination

Time frame: 60 month

Incremental cost-utility ratio of MPT compared with anticoagulation strategy

Time frame: 60 month

Net financial impact over 5 years of TPM distribution

Time frame: 60 month

Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts