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

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.

• 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.

Study Overview

• Status: Recruiting
• Conditions: Iliofemoral Venous Thrombosis
• Intervention / Treatment: Device: pharmaco mechanical thrombolysis

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.

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Olivier Espitia, Dr; Phone Number: 02 40 08 33 55; Email: olivier.espitia@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44000
    • Recruiting
    • Dr Olivier Espitia
    • Contact: Olivier Espitia, dr; Phone Number: +33 2 40 08 33 55; Email: olivier.espitia@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pharmaco mechanical thrombolysis; thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants	Device: pharmaco mechanical thrombolysis; arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants
Active Comparator: 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.	Device: pharmaco mechanical thrombolysis; arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Villalta score greater than or equal to 10	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	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	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.	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	overall assessment by questionnaire	1,30 and 60 month
CIVIQ 20	score 0 to 100	1,30 and 60 month
SF36 scores	score 0 to 100	1,30 and 60 month
Number of patients with onset of venous claudication	Number of patients with onset of venous claudication	30 month
Number of patients with a trophic disorder, assessed by clinical examination	Number of patients with a trophic disorder, assessed by clinical examination	60 month
Incremental cost-utility ratio of MPT compared with anticoagulation strategy	Incremental cost-utility ratio of MPT compared with anticoagulation strategy	60 month
Net financial impact over 5 years of TPM distribution	Net financial impact over 5 years of TPM distribution	60 month

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: RC22_0472

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No