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

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

Study Overview

• Status: Completed
• Conditions: Post-thrombotic Syndrome; Iliac Vein Compression Syndrome
• Intervention / Treatment: Device: sinus-Obliquus Stent System

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1090
    • Allgemeines Krankenhaus der Stadt Wien
• Germany
  • Arnsberg, Germany, 59759
    • Karolinen Hospital Arnsberg
  • Heidelberg, Germany, 69120
    • Medizinische Universitatsklinik Heidelberg
  • Homburg, Germany, 66424
    • Universität des Saarlandes
• Netherlands
  • Maastricht, Netherlands, 6229
    • Maastricht University Hospital MUMC+
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitätsspital Bern
  • Zürich, Switzerland, 8091
    • Universitatsspital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with post-thrombotic syndrome and concomitant common iliac vein compression.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Optimed Medizinische Instrumente GmbH
• Investigators: Principal Investigator: Nils Kucher, Prof. Dr. med., Director Clinic for Angiology Universitätsspital Zürich

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Congenital Abnormalities; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Cardiovascular Abnormalities; Vascular Malformations; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Syndrome; Postthrombotic Syndrome; Postphlebitic Syndrome; May-Thurner Syndrome
• Other Study ID Numbers: SONIS15473