Recruiting PHASE4 Iliofemoral Venous Thrombosis

Compares treatment options for Iliofemoral Venous Thrombosis

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

ClinicalTrials.gov ID: NCT06472518

What this study is testing

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...
  • Visual analog scale greater than or equal to 5 and/or

You likely can't join if

  • 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.
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Nantes, France

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Nantes, France. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.