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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pharmaco mechanical thrombolysis | Experimental | thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmaco mechanical thrombolysis | Device | arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants |
|
| 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 |
| 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 |
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Inclusion Criteria:
And at least 1 of the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier Espitia, Dr | Contact | 02 40 08 33 55 | olivier.espitia@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Olivier Espitia | Recruiting | Nantes | 44000 | France |
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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 |