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

Not Applicable

Terminated

• Conditions: Venous Thrombosis
• Interventions: Device: Gore Viabahn Heparin Coated Stent

• Registration Number: NCT01406795
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-07-22
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-08-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-11-24
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-06
• Last Update Submitted: 2017-01-06
• Results First Posted: 2017-02-27
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venous Stent Arm	Gore Viabahn Heparin Coated Stent	The study is a single treatment arm study and the venous stent will be placed in all eligible participants.

Primary Outcome Measures

Name	Time	Method
Stent Migration	up to one year following the procedure 1 year	Stent migration is reported as the count of participants with stent migration within 1 year following stent placement.
Primary Patency Rate	up to 1 year following the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Secondary Patency	up to 1 year	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.
Decrease in Swelling of Affected Extremity	up to 2 years	The count of participants that experienced a decrease in swelling after the stent was placed.
Freedom From Device-related Amputation	up to 1 year following the procedure	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.
Assisted-primary Patency	up to 1 year	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.
Adverse Events	up to two years 2 years	Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure.
Venous Clinical Severity Score	up to 2 years	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.
VEINS-QOL	Up to 2 years	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.
Villalta PTS Scale	up to 2 years	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States