Pharmaco-mechanical thrombolysis plus anticoagulation vs anticoagulation alone for acute iliofemoral DVT
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.
Run by Nantes University Hospital · NCT06472518 · Data updated 2026-11-12
This trial tests whether adding pharmaco-mechanical thrombolysis to standard anticoagulation helps people with acute iliofemoral DVT.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 228 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Status | Recruiting |
| Started | May 20, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | September 1, 2029 |
| Registry record updated | May 26, 2026 |
| Trial ID | NCT06472518 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with recent iliofemoral (iliac and/or common femoral) DVT, willing to consent and with sufficient data coverage.
✕Probably not a fit
Patients with thrombosis not extending to the iliac veins or with contraindications to thrombolysis may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with acute iliofemoral venous thrombosis are randomized to receive pharmaco-mechanical thrombolysis with anticoagulation or anticoagulation alone. Those in the anticoagulation-only arm may later receive stenting or angioplasty if they develop moderate post-thrombotic syndrome or venous claudication. The study follows participants for 30 months to assess health outcomes and also includes a medico-economic analysis. Results will inform medium- and long-term benefits and costs in the French healthcare setting.
Why it matters
Potential benefit: If successful, the approach could reduce long-term complications and improve symptoms for patients with iliofemoral DVT.
How similar studies have gone: Prior studies suggest thrombolysis can be safe and beneficial in selected patients, but long-term French-context data are being gathered here.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Dr Olivier Espitia
Nantes, France Recruiting
Study contacts
- Study coordinator: Olivier Espitia, Dr
- Email: olivier.espitia@chu-nantes.fr
- Phone: 02 40 08 33 55
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.