Bern Venous Stent Registry

October 11, 2023 updated by: Nils Kucher, University of Zurich
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

548

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8091
        • Klinik für Angiologie, Universitätsspital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with symptoms of chronic venous disease and obstruction and/or stenosis of the iliofemoral veins and/or inferior vena cava.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CE-certified dedicated venous stents
Patients receiving self-expanding venous nitinol stents.
Device: CE-certified dedicated venous stents
Implantation of self-expanding nitinol venous stents in the iliofemoral veins and/or inferior vena cava.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary patency rate
Time Frame: after one year up to a follow-up of five years
after one year up to a follow-up of five years

Secondary Outcome Measures

Outcome Measure
Time Frame
Primary assisted patency rate
Time Frame: after one year up to a follow-up of five years
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
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
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
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
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
after one year up to a follow-up of five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Nils Kucher, Prof. Dr. med., University Hospital Zurich, Clinic of Angiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

April 11, 2023

Study Completion (Actual)

October 11, 2023

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimated)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 262/ 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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