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OpenTrials
Completed

NCT Number: NCT02942394

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

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

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Key information

Conditions

Post-thrombotic Syndrome Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Embolism and Thrombosis Iliac Vein Compression Syndrome May-Thurner Syndrome Peripheral Vascular Diseases Postthrombotic Syndrome Thrombosis Vascular Diseases Vascular Malformations Venous Insufficiency Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Allgemeines Krankenhaus der Stadt Wien, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female adults aged ≥18 years
  • Post-thrombotic syndrome (Villalta score >4 points) due to iliac vein thrombosis with or without femoral deep vein thrombosis
  • Evidence of venous stenosis in common iliac vein >50% confirmed by venography (CT or MRI) or intravascular ultrasound (IVUS)
  • Use of sinus-Obliquus stent for unilateral common iliac vein stenosis
  • 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

  • Pregnancy, breast-feeding or birth-giving during the last 30 days
  • Life expectancy <6 months
  • Iliofemoral DVT less than 3 months ago
  • Permanently immobile patient (wheelchair user or bed-ridden patient)
  • Allergy to Nitinol
  • Patient's target vessel(s) has/have been stented before
  • Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
  • Patients in custody by juridical or official order

Treatment and study plan

sinus-Obliquus Stent System

Device

Primary outcomes

  1. Primary Patency Rate

    Time frame: After 3 months up to a follow-up of 2 years.

Secondary outcomes

  1. Primary Assisted Patency Rate

    Time frame: After 3 months up to a follow-up of 2 years.

  2. Secondary Patency Rate

    Time frame: After 3 months up to a follow-up of 2 years.

Sponsors and collaborators

Lead sponsor

Optimed Medizinische Instrumente GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 24, 2016
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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