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

Post-thrombotic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942394
• Other study ID #: SONIS15473
• Status: Completed
• Start date: December 2016
• Est. completion date: December 17, 2020

Study information

• Verified date: January 2021
• Source: Optimed Medizinische Instrumente GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 17, 2020
• Est. primary completion date: December 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Iliac Vein Compression Syndrome
• May-Thurner Syndrome
• Post-thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Syndrome

Intervention

Device:
• sinus-Obliquus Stent System

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus der Stadt Wien	Wien
Germany	Karolinen Hospital Arnsberg	Arnsberg
Germany	Medizinische Universitätsklinik Heidelberg	Heidelberg
Germany	Universität des Saarlandes	Homburg
Netherlands	Maastricht University Hospital MUMC+	Maastricht
Switzerland	INSELSPITAL, Universitätsspital Bern	Bern
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Optimed Medizinische Instrumente GmbH

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands,  Switzerland, 

Outcome

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