Mesenteric Venous Thrombosis Clinical Trials

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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.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Dr Olivier Espitia
RECRUITING
Nantes
Contact Information
Primary
Olivier Espitia, Dr
olivier.espitia@chu-nantes.fr
02 40 08 33 55
Time Frame
Start Date: 2026-05-20
Estimated Completion Date: 2029-09-01
Participants
Target number of participants: 228
Treatments
Experimental: pharmaco mechanical thrombolysis
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.
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov