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

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

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 Overview

• Status: Terminated
• Conditions: Venous Thrombosis
• Intervention / Treatment: Device: Gore Viabahn Heparin Coated Stent

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Venous Stent Arm; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Dr. Lawrence (Rusty) Hofmann MD, Stanford University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 22, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (Estimate): August 1, 2011

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: January 6, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Post Thrombotic Syndrome; Venous Stenosis; Venous Stasis; Venous Occlusions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Pathological Conditions, Anatomical; Thrombosis; Venous Thrombosis; Constriction, Pathologic; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: SU-01312011-7377; FDA IDE - G090054; IRB eProtocol - 14781; SPO # 49275