Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.
NCT Number: NCT06472518
Acronym: PMT-DVT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Iliofemoral Venous Thrombosis
Interventions: DEVICE: pharmaco mechanical thrombolysis
Sponsor: Nantes University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 228
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-09-01

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.

Primary Outcome Measures: 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: 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