Bern Venous Stent Registry

Study Overview
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Brief Summary
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The purpose of this study is to examine patency rates of self-expanding nitinol stents for treatment of iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis. Moreover, clinical outcome data of patients treated with these venous stents will be collected.

Detailed Description
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Background: Obstruction and stenosis of the ilio-femoro-caval veins are difficult to treat by conservative measures only. Despite anticoagulation and consequent use of compression stockings, lower extremity venous hypertension affects patients quality of life and health status by causing venous claudication, swelling, skin changes, and venous ulcers. In the last decades venous stenting has become an accepted treatment for ilio-femoro-caval obstruction. Recently, novel self-expanding nitinol stents have been specifically designed for the venous system to account for the anatomical structure of ilio-femoro-caval veins. Gap of Knowledge: There are few data on short and long term outcomes of self-expanding Nitinol stent placement in ilio-femoro-caval veins. Objective: To study patency rates and clinical outcome data of self-expanding Nitinol stents that were specifically designed for iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis.

Official Title
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Bern Venous Stent Registry

Conditions
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Post-thrombotic Syndrome

Intervention / Treatment
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* Device: CE-certified dedicated venous stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving self-expanding venous nitinol stents for one of the following indications: Residual thrombosis of iliofemoral veins and/or inferior vena cava after thrombus removal (by catheter-directed thrombolysis or pharmacomechanical thrombolysis) Post-thrombotic syndrome and chronic obstruction of iliofemoral veins and/or inferior vena cava Chronic venous insufficiency and presence of non-thrombotic venous stenosis of iliofemoral veins and/or inferior vena cava Exclusion Criteria: No consent Inability to provide informed consent Allergy to Nitinol Pregnancy, breast-feeding or birth-giving during the last 30 days Life expectancy <3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CE-certified dedicated venous stents<br>Patients receiving self-expanding venous nitinol stents. | Device: CE-certified dedicated venous stents<br>* Implantation of self-expanding nitinol venous stents in the iliofemoral veins and/or inferior vena cava.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency rate |  | after one year up to a follow-up of five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary assisted patency rate |  | after one year up to a follow-up of five years | 
| Target vessel revascularization |  | after one year up to a follow-up of five years | 
| Secondary patency rate |  | after one year up to a follow-up of five years | 
| Revised Venous Clinical Severity Score |  | after one year up to a follow-up of five years | 
| CEAP-Score |  | after one year up to a follow-up of five years | 
| Adverse events: Stent-related: Rethrombosis (early and late), In-Stent restenosis, Stent compression/fracture Clinical: Postthrombotic syndrome, Bleeding (major, minor), Death (VTE-related, Bleeding-related, other), Recurrent VTE at any site |  | after one year up to a follow-up of five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep vein thrombosis, chronic venous disease, May-Thurner syndrome, venous stent