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

Completed

• Conditions: Iliac Vein Compression Syndrome; Post-thrombotic Syndrome

• Registration Number: NCT02942394
• Lead Sponsor: Optimed Medizinische Instrumente GmbH

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-24
• Study Start: 2016-12
• Primary Completion: 2020-12-17
• Study Completion: 2020-12-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

Karolinen Hospital Arnsberg; 🇩🇪 Arnsberg, Germany

Medizinische Universitätsklinik Heidelberg; 🇩🇪 Heidelberg, Germany

Universität des Saarlandes; 🇩🇪 Homburg, Germany

Maastricht University Hospital MUMC+; 🇳🇱 Maastricht, Netherlands

Allgemeines Krankenhaus der Stadt Wien; 🇦🇹 Wien, Austria

INSELSPITAL, Universitätsspital Bern; 🇨🇭 Bern, Switzerland

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland