Bern Venous Stent Registry

  • STATUS
    Recruiting
  • End date
    Dec 19, 2030
  • participants needed
    500
  • sponsor
    University of Zurich
Updated on 19 November 2021

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.

Details
Condition Venous stasis, post thrombotic syndrome
Treatment CE-certified dedicated venous stents
Clinical Study IdentifierNCT02433054
SponsorUniversity of Zurich
Last Modified on19 November 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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