The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses

Study Overview
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Brief Summary
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To study the safety and efficacy of drug coated stents for the treatment of venous occlusions and stenoses in the lower extremity. The use of the device for the treatment of peripheral arterial disease is approved by the FDA, however, the use of the device in venous occlusions and stenoses, although performed by some practitioners, has not yet been studied in detail.

Official Title
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Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses

Conditions
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Venous Thrombosis

Intervention / Treatment
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* Device: Gore Viabahn Heparin Coated Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 years old Patient has clinical manifestations (i.e. symptoms and/or signs) of chronic DVT of an extremity. The Venous Clinical Severity Score (VCSS) will be used to determine if the patient is currently suffering from chronic DVT, with a VCSS score of 4 or greater necessary for inclusion. Imaging confirmation of venous occlusion or stenosis (>50%) involving the femoral, and/or popliteal veins Obstructed vessel caliber can accommodate a 7FR System, from insertion site to target segment Patient is able to read and answer a questionnaire in English Exclusion Criteria: History of life-threatening reaction to contrast material Unwilling or unable to provide informed consent, or return for required follow-up evaluations Participating in another investigational study that has not completed follow-up testing Cannot receive outpatient anticoagulation such as LMWH and/or vitamin K antagonists (VKAs) Absolute contraindication to contrast media or renal insufficiency (baseline creatinine >2.0 mg/dL). Either a history or presence of heparin-induced thrombocytopenia antibodies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venous Stent Arm<br>The study is a single treatment arm study and the venous stent will be placed in all eligible participants. | Device: Gore Viabahn Heparin Coated Stent<br>* For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Migration | Stent migration is reported as the count of participants with stent migration within 1 month following stent placement. | up to 1 month following the procedure | 
| Stent Migration | Stent migration is reported as the count of participants with stent migration within 1 year following stent placement. | up to one year following the procedure 1 year | 
| Primary Patency Rate | Patency refers to whether the stent is unoccluded (open). Primary patency rate was defined as the count of participants with >= 50% patency following initial stent placement, and is reported as the count of participants meeting this criteria. | up to 1 year following the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Device-related Amputation | Freedom from device-related amputation (amputation of infected limb) is reported as the count of participants with no device-related amputation within 1 year following stent placement. | up to 1 year following the procedure | 
| Assisted-primary Patency | Patency refers to whether the stent is unoccluded (open). Primary refers to the first time a stent was placed (or the first time patency needed to be established). Assisted refers to the fact that a device (like a balloon) was used to open the stent. Assisted-primary patency is defined as the count of participants that demonstrated the need for an intervention to establish patency. | up to 1 year | 
| Secondary Patency | Secondary patency means that the initial intervention failed and a second intervention was performed to establish or maintain patency. Secondary patency is defined as the count of participants that required a second intervention to establish patency. | up to 1 year | 
| Adverse Events | Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure. | up to two years 2 years | 
| Decrease in Swelling of Affected Extremity | The count of participants that experienced a decrease in swelling after the stent was placed. | up to 2 years | 
| Venous Clinical Severity Score | Venous Clinical Severity represents the severity of the venous pathology, which includes measures like pain, inflammation, and number of ulcers. It is scored on a scale of 0-3 with the upper end representing very severe outcomes for the patient. | up to 2 years | 
| VEINS-QOL | The VEINS-QOL is a questionnaire that represents a patient's quality of life, using measures like how well the patient can walk, sleep, and enjoy life. Responses are graded on a scale of 1-5, with 1 being very good, and 5 being very poor. The VEINS-QOL measure is defined by the count of participants that showed a decreased overall score following their procedure. | Up to 2 years | 
| Villalta PTS Scale | The Villalta PTS Scale is a score based on the patient's symptoms, includes cramps, pain, and redness. It is scaled from 0 to 48, with a higher score representing more severe disease. | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Thrombotic Syndrome, Venous Stasis, Venous Occlusions, Venous Stenosis