Treatment of the Postthrombotic Syndrome With the Oblique Stent - TOPOS Study

Optimed Medizinische Instrumente

Status: Completed

Conditions: Iliac Vein Compression Syndrome; Post-thrombotic Syndrome

Treatments: Device: sinus-Obliquus Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT02942394

SONIS15473

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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