Clinical trial NCT02942394: Treatment of the Postthrombotic Syndrome With the Oblique Stent - TOPOS Study
Official title: Non-interventional, Multicenter, Multinational Venous Stent Study for the Treatment of the Post-thrombotic Syndrome With Common Iliac Vein Compression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-thrombotic Syndrome
Iliac Vein Compression Syndrome
Lead sponsor: Optimed Medizinische Instrumente GmbH
Sponsor class: INDUSTRY
First posted: 2016-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with post-thrombotic syndrome and concomitant common iliac vein compression.

Brief summary: 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


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

Primary outcomes:
measure: Primary Patency Rate
timeFrame: After 3 months up to a follow-up of 2 years.
Secondary outcomes:
measure: Primary Assisted Patency Rate
timeFrame: After 3 months up to a follow-up of 2 years.
measure: Secondary Patency Rate
timeFrame: After 3 months up to a follow-up of 2 years.
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Arnsberg
country: Germany
facility: Karolinen Hospital Arnsberg
city: Heidelberg
country: Germany
facility: Medizinische Universitätsklinik Heidelberg
city: Homburg
country: Germany
facility: Universität des Saarlandes
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital MUMC+
city: Bern
country: Switzerland
facility: INSELSPITAL, Universitätsspital Bern
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Director Clinic for Angiology Universitätsspital Zürich
name: Nils Kucher, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: