Bern Venous Stent Registry

Completed

• Conditions: Post-thrombotic Syndrome
• Interventions: Device: CE-certified dedicated venous stents

• Registration Number: NCT02433054
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-05-04
• Primary Completion: 2023-04-11
• Status Verified: 2023-10
• Study Completion: 2023-10-11
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 548

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CE-certified dedicated venous stents	CE-certified dedicated venous stents	Patients receiving self-expanding venous nitinol stents.

Primary Outcome Measures

Name	Time	Method
Primary patency rate	after one year up to a follow-up of five years

Secondary Outcome Measures

Name	Time	Method
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
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
Primary assisted 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

Trial Locations

Locations (1)

Klinik für Angiologie, Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland