Clinical Trial: Treatment of the Postthrombotic Syndrome With the Oblique Stent - TOPOS Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Non-interventional, Multicenter, Multinational Venous Stent Study for the Treatment of the Post-thrombotic Syndrome With Common Iliac Vein Compression
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 Summary:
Sponsor: Optimed Medizinische Instrumente GmbH
Current Primary Outcome: Primary Patency Rate [ Time Frame: After 3 months up to a follow-up of 2 years. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Primary Assisted Patency Rate [ Time Frame: After 3 months up to a follow-up of 2 years. ]
- Secondary Patency Rate [ Time Frame: After 3 months up to a follow-up of 2 years. ]
Original Secondary Outcome: Same as current
Information By: Optimed Medizinische Instrumente GmbH
Dates:
Date Received: October 19, 2016
Date Started: December 2016
Date Completion: October 2019
Last Updated: February 28, 2017
Last Verified: February 2017
