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NOT YET RECRUITING
NCT06472518
PHASE4

Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

228

Start Date

2024-09-01

Completion Date

2029-09-01

Last Updated

2024-06-25

Healthy Volunteers

No

Interventions

DEVICE

pharmaco mechanical thrombolysis

arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants