Dr Olivier Espitia
Nantes, 44000, France
Location status: Recruiting
NCT Number: NCT06472518
* 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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Nantes, 44000, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
And at least 1 of the following criteria:
Exclusion criteria
arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants
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
Time frame: 30 month
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
Time frame: 1, 30 and 60 month
Number of major hemorrhages and number of clinically relevant non-major hemorrhages according to ISTH criteria
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.
Time frame: 1,30 and 60 month
overall assessment by questionnaire
Time frame: 1,30 and 60 month
score 0 to 100
Time frame: 1,30 and 60 month
score 0 to 100
Time frame: 30 month
Number of patients with onset of venous claudication
Time frame: 60 month
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
Time frame: 60 month
Net financial impact over 5 years of TPM distribution
Contact information is provided by the study sponsor or research team.
Nantes University Hospital
Other
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
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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.