Primary objective:
To assess the efficacy of the stents (sinus-Obliquus stent for the common iliac vein, the sinus-XL Flex stent or sinus-Venous stent for the external iliac and common femoral veins) by evaluating different gradations of patency rates, patient's rating of disease severity and quality of life in patients with post-thrombotic syndrome and concomitant common iliac vein compression.
Secondary objective:
To assess long-term safety of venous stenting
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female adults aged ≥18 years
✓. Post-thrombotic syndrome (Villalta score \>4 points) due to iliac vein thrombosis with or without femoral deep vein thrombosis
✓. Evidence of venous stenosis in common iliac vein \>50% confirmed by venography (CT or MRI) or intravascular ultrasound (IVUS)
✓. Use of sinus-Obliquus stent for unilateral common iliac vein stenosis
✓. If stent extension is required either sinus-XL Flex or sinus-Venous stents must have been used for stenoses \>50% confirmed by venography (CT or MRI) or IVUS in external iliac and common femoral veins
Exclusion criteria
✕. Pregnancy, breast-feeding or birth-giving during the last 30 days
✕. Life expectancy \<6 months
✕. Iliofemoral DVT less than 3 months ago
✕. Permanently immobile patient (wheelchair user or bed-ridden patient)
✕. Allergy to Nitinol
✕. Patient's target vessel(s) has/have been stented before
✕. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
✕
What they're measuring
1
Primary Patency Rate
Timeframe: After 3 months up to a follow-up of 2 years.