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

Stanford University1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Thrombosis

Interventions

Gore Viabahn Heparin Coated StentDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

Stent Migration

Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.

Time frame: 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.

Time frame: 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.

Time frame: up to 1 year following the procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.