Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT02942394
Eligibility Criteria:
Inclusion Criteria:
1. Male or female adults aged ≥18 years
2. Post-thrombotic syndrome (Villalta score \>4 points) due to iliac vein thrombosis with or without femoral deep vein thrombosis
3. Evidence of venous stenosis in common iliac vein \>50% confirmed by venography (CT or MRI) or intravascular ultrasound (IVUS)
4. Use of sinus-Obliquus stent for unilateral common iliac vein stenosis
5. 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:
1. Pregnancy, breast-feeding or birth-giving during the last 30 days
2. Life expectancy \<6 months
3. Iliofemoral DVT less than 3 months ago
4. Permanently immobile patient (wheelchair user or bed-ridden patient)
5. Allergy to Nitinol
6. Patient's target vessel(s) has/have been stented before
7. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
8. Patients in custody by juridical or official order
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02942394
Study Brief:
Protocol Section:
NCT02942394