Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Jan 30, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment options for patients suffering from Post-Thrombotic Syndrome (PTS), a condition that can occur after a deep vein thrombosis (DVT) in the leg, particularly in the iliac vein. The trial will compare the benefits of a procedure called angioplasty-stenting, which involves using a small balloon and a stent to open blocked veins, against optimal medical treatment, which includes medications. The goal is to see if the angioplasty-stenting procedure can reduce the symptoms of PTS more effectively than medication alone.

To participate in this trial, individuals must be at least 18 years old and have disabling symptoms of PTS for more than six months after experiencing a DVT that involved the iliac vein. Participants will be closely monitored throughout the study to assess their symptoms and any potential side effects from the treatments. It's important to note that while angioplasty-stenting is becoming a more common procedure, it is still considered experimental, which means there are some risks involved. Patients interested in this trial should discuss it with their healthcare provider to see if it might be a suitable option for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient age ≥ 18 years' old
• • Patient with disabling PTS defined as a Villalta score ≥ 10, more than 6 months after unilateral proximal deep vein thrombosis (first or recurrent episode) involving at least iliac vein. A contralateral distal or superficial vein thrombosis was not considered as bilateral thrombosis.
• Rational for main inclusion criteria:
• • Patients would be screened more than 6 months after the index DVT event to be sure that symptoms were related to chronic phase of PTS and not to the acute DVT event.
• • Although endovascular therapy has actually matured to propose a systematic evaluation, the procedure remains experimental with potential risks. Therefore, the study must focus on patients with advanced PTS and iliofemoral obstruction, since this population appears to have the greatest attempted benefit.
• Exclusion Criteria:
• • Index DVT without iliac thrombosis
• • Bilateral proximal deep vein thrombosis or Inferior vena cava thrombosis
• • Lower limb arteriopathy defined as ante-brachial index \< 0.5
• • Vena cava filter
• • Venous ulcers ≥ 50 cm²
• • Life expectancy \< 6 months
• • Contraindication to anticoagulant treatment by direct oral anticoagulant
• • Contraindication to the use of low-dose aspirin (100 mg)
• • Use of dual antiplatelet agents aspirin/clopidogrel
• • Use of Prasugrel or Ticagrelor
• • Previous venous recanalization of the same leg
• • Impossible to follow-up
• • Contraindication to contrast iodine
• • Renal insufficiency (Cockroft \<30 ml/min, (less than 3 months old))
• • Subject in exclusion period from another study,
• • Pregnant or breastfeeding women
• • Subject under administrative or judicial control
• • Subject under legal protection
• • Subject hospitalized for psychiatric care