search
Back to results

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

Primary Purpose

Venous Thrombosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gore Viabahn Heparin Coated Stent
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thrombosis focused on measuring Post Thrombotic Syndrome, Venous Stasis, Venous Occlusions, Venous Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Venous Stent Arm

Arm Description

The study is a single treatment arm study and the venous stent will be placed in all eligible participants.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Adverse Events
Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure.
Decrease in Swelling of Affected Extremity
The count of participants that experienced a decrease in swelling after the stent was placed.
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.
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.
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.

Full Information

First Posted
July 22, 2011
Last Updated
January 6, 2017
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT01406795
Brief Title
The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses
Official Title
Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment and advances in venoplasty only techniques of the femoral vein
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis
Keywords
Post Thrombotic Syndrome, Venous Stasis, Venous Occlusions, Venous Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Venous Stent Arm
Arm Type
Experimental
Arm Description
The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Intervention Type
Device
Intervention Name(s)
Gore Viabahn Heparin Coated Stent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stent Migration
Description
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
Title
Stent Migration
Description
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
Title
Primary Patency Rate
Description
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 Outcome Measure Information:
Title
Freedom From Device-related Amputation
Description
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
Title
Assisted-primary Patency
Description
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
Title
Secondary Patency
Description
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.
Time Frame
up to 1 year
Title
Adverse Events
Description
Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure.
Time Frame
up to two years 2 years
Title
Decrease in Swelling of Affected Extremity
Description
The count of participants that experienced a decrease in swelling after the stent was placed.
Time Frame
up to 2 years
Title
Venous Clinical Severity Score
Description
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.
Time Frame
up to 2 years
Title
VEINS-QOL
Description
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.
Time Frame
Up to 2 years
Title
Villalta PTS Scale
Description
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.
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Lawrence (Rusty) Hofmann MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs