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

NCT06472518 | Recruiting Phase 4

• 1 other identifier: RC22_0472
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Iliofemoral Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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

  30 month

Secondary Outcomes (11)

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

  30 month

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

  30 month

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

  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.

  1 month

• VEIN-QOL

  1,30 and 60 month

Study Arms (2)

pharmaco mechanical thrombolysis

EXPERIMENTAL

thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants

Device: pharmaco mechanical thrombolysis

oral anticoagulant alone

ACTIVE COMPARATOR

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.

Device: pharmaco mechanical thrombolysis

Interventions

pharmaco mechanical thrombolysis DEVICE

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

oral anticoagulant alone; pharmaco mechanical thrombolysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Dr Olivier Espitia

Nantes, 44000, France

RECRUITING

Central Study Contacts

Olivier Espitia, Dr

CONTACT

02 40 08 33 55; olivier.espitia@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: June 25, 2024
• Study Start: May 20, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)