NCT02433054

Bern Venous Stent Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 548 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Post-thrombotic Syndrome

Interventions

Type	Name	Description
DEVICE	CE-certified dedicated venous stents	Implantation of self-expanding nitinol venous stents in the iliofemoral veins and/or inferior vena cava.

Timeline

• Start date: 2015-01-01
• Primary completion: 2023-04-11
• Completion: 2023-10-11
• First posted: 2015-05-04
• Last updated: 2023-10-12

Locations

1 site across 1 country: Switzerland