NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.
| NCT ID | NCT06472518 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nantes University Hospital |
| Condition | Iliofemoral Venous Thrombosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2026-05-20 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 228 participants in total. It began in 2026-05-20 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patients who agreed to participate in the study and gave oral consent. * Patient affiliated to a social security scheme * Iliac and/or common femoral venous thrombosis * Recent thrombosis less than or equal to 14 days since qualifying imaging or less than or equal to 21 days since onset of symptoms And at least 1 of the following criteria: * Visual analog scale greater than or equal to 5 and/or * Venous claudication and/or * Increase in thigh circumference greater than or equal to 5% compared with contralateral thigh. Exclusion Criteria: * Patients with superficial femoral or popliteal venous thrombosis without involvement of the common femoral or iliac veins. * Patients with isolated thrombosis of the inferior vena cava, without extension to the iliac veins. * Thrombosis of inferior vena cava proximal to the renal veins. * Minors, pregnant women, adults under guardianship. * Chronic renal failure with creatinine clearance below 30ml/min according to Cockroft. * Ischaemic phlebitis: proximal venous thrombosis associated with limb ischemia and impaired arterial flow.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06472518 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Iliofemoral Venous Thrombosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06472518 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06472518 currently recruiting?
Yes, NCT06472518 is actively recruiting participants. Contact the research team at olivier.espitia@chu-nantes.fr for enrollment information.
Where is the NCT06472518 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT06472518 clinical trial?
NCT06472518 is sponsored by Nantes University Hospital. The trial plans to enroll 228 participants.