Bern Venous Stent Registry

Post-thrombotic Syndrome Clinical Trial

Official title:

Bern Venous Stent Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433054
• Other study ID #: 262/ 2014
• Status: Completed
• Start date: January 2015
• Est. completion date: October 11, 2023

Study information

• Verified date: October 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 548
• Est. completion date: October 11, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome

Intervention

Device:
• CE-certified dedicated venous stents
Implantation of self-expanding nitinol venous stents in the iliofemoral veins and/or inferior vena cava.

Locations

Country	Name	City	State
Switzerland	Klinik für Angiologie, Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency rate		after one year up to a follow-up of five years
Secondary	Primary assisted patency rate		after one year up to a follow-up of five years
Secondary	Target vessel revascularization		after one year up to a follow-up of five years
Secondary	Secondary patency rate		after one year up to a follow-up of five years
Secondary	Revised Venous Clinical Severity Score		after one year up to a follow-up of five years
Secondary	CEAP-Score		after one year up to a follow-up of five years
Secondary	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