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Completed

NCT Number: NCT02433054

Bern Venous Stent Registry

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CE-certified dedicated venous stents

Device

Implantation of self-expanding nitinol venous stents in the iliofemoral veins and/or inferior vena cava.

Primary outcomes

  1. Primary patency rate

    Time frame: after one year up to a follow-up of five years

Secondary outcomes

  1. Primary assisted patency rate

    Time frame: after one year up to a follow-up of five years

  2. Target vessel revascularization

    Time frame: after one year up to a follow-up of five years

  3. Secondary patency rate

    Time frame: after one year up to a follow-up of five years

  4. Revised Venous Clinical Severity Score

    Time frame: after one year up to a follow-up of five years

  5. CEAP-Score

    Time frame: after one year up to a follow-up of five years

  6. 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
May 4, 2015
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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