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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sinus-Obliquus Stent System | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency Rate | After 3 months up to a follow-up of 2 years. |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with post-thrombotic syndrome and concomitant common iliac vein compression.
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| Name | Affiliation | Role |
|---|---|---|
| Nils Kucher, Prof. Dr. med. | Director Clinic for Angiology Universitätsspital Zürich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus der Stadt Wien | Vienna | 1090 | Austria | |||
| Karolinen Hospital Arnsberg |
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| ID | Term |
|---|---|
| D054070 | Postthrombotic Syndrome |
| D062108 | May-Thurner Syndrome |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| Arnsberg |
| 59759 |
| Germany |
| Medizinische Universitätsklinik Heidelberg | Heidelberg | 69120 | Germany |
| Universität des Saarlandes | Homburg | 66424 | Germany |
| Maastricht University Hospital MUMC+ | Maastricht | 6229 | Netherlands |
| INSELSPITAL, Universitätsspital Bern | Bern | 3010 | Switzerland |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| D002318 |
| Cardiovascular Diseases |
| D014689 | Venous Insufficiency |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D016491 | Peripheral Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |