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.
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.
Study Type
OBSERVATIONAL
Enrollment
548
Implantation of self-expanding nitinol venous stents in the iliofemoral veins and/or inferior vena cava.
Klinik für Angiologie, Universitätsspital Zürich
Zurich, Switzerland
Primary patency rate
Time frame: after one year up to a follow-up of five years
Primary assisted patency rate
Time frame: after one year up to a follow-up of five years
Target vessel revascularization
Time frame: after one year up to a follow-up of five years
Secondary patency rate
Time frame: after one year up to a follow-up of five years
Revised Venous Clinical Severity Score
Time frame: after one year up to a follow-up of five years
CEAP-Score
Time frame: 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
Time frame: after one year up to a follow-up of five years
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