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

Non-interventional, Multicenter, Multinational Venous Stent Study for the Treatment of the Post-thrombotic Syndrome With Common Iliac Vein Compression

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02942394

Enrollment

Registered

2016-10-24

Start date

2016-12-31

Completion date

2020-12-17

Last updated

2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iliac Vein Compression Syndrome, Post-thrombotic Syndrome

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

Interventions

DEVICEsinus-Obliquus Stent System

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Primary Patency Rate	After 3 months up to a follow-up of 2 years.

Secondary

Measure	Time frame
Primary Assisted Patency Rate	After 3 months up to a follow-up of 2 years.
Secondary Patency Rate	After 3 months up to a follow-up of 2 years.

Countries

Austria, Germany, Netherlands, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026