A Phase 4 interventional study of pharmaco mechanical thrombolysis in Iliofemoral Venous Thrombosis, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Nantes University Hospital · Phase 4, Interventional, and Treatment
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.
Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
And at least 1 of the following criteria:
Exclusion Criteria:
thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants
Device: pharmaco mechanical thrombolysis
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
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
Time frame: 30 month
Number of patients with Villalta score greater than or equal to 10
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 15, or presence of ulceration
Number of patients with Villalta score greater than or equal to 15, or presence of ulceration
Time frame: 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
Time frame: 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.
Time frame: 1 month
VEIN-QOL
overall assessment by questionnaire
Time frame: 1,30 and 60 month
CIVIQ 20
score 0 to 100
Time frame: 1,30 and 60 month
SF36 scores
score 0 to 100
Time frame: 1,30 and 60 month
Number of patients with onset of venous claudication
Number of patients with onset of venous claudication
Time frame: 30 month
Number of patients with a trophic disorder, assessed by clinical examination
Number of patients with a trophic disorder, assessed by clinical examination
Time frame: 60 month
Incremental cost-utility ratio of MPT compared with anticoagulation strategy
Incremental cost-utility ratio of MPT compared with anticoagulation strategy
Time frame: 60 month
Net financial impact over 5 years of TPM distribution
Net financial impact over 5 years of TPM distribution
Time frame: 60 month
Plan to share: No
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Nantes University Hospital