Bern Venous Stent Registry

University of Zurich (UZH)

Status: Completed

Conditions: Post-thrombotic Syndrome

Treatments: Device: CE-certified dedicated venous stents

Study type: Observational

Funder types: Other

Identifiers

NCT02433054

262/ 2014

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 548 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

548 participants in 1 patient group

CE-certified dedicated venous stents

Description:

Patients receiving self-expanding venous nitinol stents.

Treatment:

Device: CE-certified dedicated venous stents