Bern Venous Stent Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

548 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2023-10-11

Brief Summary

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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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Detailed Description

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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.

Conditions

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Post-thrombotic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CE-certified dedicated venous stents

Patients receiving self-expanding venous nitinol stents.

CE-certified dedicated venous stents

Intervention Type DEVICE

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

Interventions

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CE-certified dedicated venous stents

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No