Post-thrombotic Syndrome
Conditions
Keywords
deep vein thrombosis, chronic venous disease, May-Thurner syndrome, venous stent
Brief 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.
Interventions
DEVICECE-certified dedicated venous stents
Implantation of self-expanding nitinol venous stents in the iliofemoral veins and/or inferior vena cava.
Sponsors
University of Zurich
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate | after one year up to a follow-up of five years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Primary assisted patency rate | 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 |
| Revised Venous Clinical Severity Score | after one year up to a follow-up of five years |
Countries
Switzerland
Outcome results
None listed