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

NCT ID: NCT06472518

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2029-09-01

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.

Conditions

Iliofemoral Venous Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pharmaco mechanical thrombolysis

thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants

Group Type: EXPERIMENTAL

pharmaco mechanical thrombolysis

Intervention Type: DEVICE

arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants

oral anticoagulant alone

a reference treatment arm for patients receiving direct oral anticoagulant alone and stenting angioplasty in case of venous claudication or moderate post-thrombotic syndrome six months after the initial thrombosis.

Group Type: ACTIVE_COMPARATOR

pharmaco mechanical thrombolysis

Intervention Type: DEVICE

arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants

Interventions

pharmaco mechanical thrombolysis

arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Olivier Espitia, Dr

Role: CONTACT

olivier.espitia@chu-nantes.fr

02 40 08 33 55

Other Identifiers

RC22_0472

Identifier Type: -

Identifier Source: org_study_id