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NCT Number: NCT06472518

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pharmaco mechanical thrombolysis

Device

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

Primary outcomes

  1. Cost-utility analysis

    Time frame: 30 month

    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

Secondary outcomes

  1. 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 10

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

    Time frame: 30 month

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

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

  4. 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

    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.

  5. VEIN-QOL

    Time frame: 1,30 and 60 month

    overall assessment by questionnaire

  6. CIVIQ 20

    Time frame: 1,30 and 60 month

    score 0 to 100

  7. SF36 scores

    Time frame: 1,30 and 60 month

    score 0 to 100

  8. Number of patients with onset of venous claudication

    Time frame: 30 month

    Number of patients with onset of venous claudication

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

    Time frame: 60 month

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

  10. Incremental cost-utility ratio of MPT compared with anticoagulation strategy

    Time frame: 60 month

    Incremental cost-utility ratio of MPT compared with anticoagulation strategy

  11. Net financial impact over 5 years of TPM distribution

    Time frame: 60 month

    Net financial impact over 5 years of TPM distribution

Study contacts

Contact information is provided by the study sponsor or research team.

Olivier Espitia, Dr

CONTACT

[email protected]

02 40 08 33 55

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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.

Acronym: PMT-DVT

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jun 25, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.