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
NCT number | NCT02942394 |
Other study ID # | SONIS15473 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | December 17, 2020 |
Verified date | January 2021 |
Source | Optimed Medizinische Instrumente GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Optimed Medizinische Instrumente GmbH |
Austria, Germany, Netherlands, Switzerland,
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. |
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