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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2021
Source Optimed Medizinische Instrumente GmbH
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


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.
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