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

This study has been terminated.
(Poor enrollment and advances in venoplasty only techniques of the femoral vein)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01406795
First Posted: August 1, 2011
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lawrence (Rusty) Hofmann, Stanford University
  Purpose
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.

Condition Intervention
Venous Thrombosis Device: Gore Viabahn Heparin Coated Stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses

Resource links provided by NLM:


Further study details as provided by Lawrence (Rusty) Hofmann, Stanford University:

Primary Outcome Measures:
  • Stent Migration [ Time Frame: up to 1 month following the procedure ]
    Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.

  • Stent Migration [ Time Frame: 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 [ Time Frame: 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:
  • Freedom From Device-related Amputation [ Time Frame: 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 [ Time Frame: 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.

  • Secondary Patency [ Time Frame: 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.

  • Adverse Events [ Time Frame: 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.

  • Decrease in Swelling of Affected Extremity [ Time Frame: up to 2 years ]
    The count of participants that experienced a decrease in swelling after the stent was placed.

  • Venous Clinical Severity Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 1
Study Start Date: December 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406795


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Lawrence (Rusty) Hofmann MD Stanford University
  More Information

Responsible Party: Lawrence (Rusty) Hofmann, Chief of Interventional Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01406795     History of Changes
Other Study ID Numbers: SU-01312011-7377
FDA IDE - G090054
IRB eProtocol - 14781
SPO # 49275
First Submitted: July 22, 2011
First Posted: August 1, 2011
Results First Submitted: November 24, 2016
Results First Posted: February 27, 2017
Last Update Posted: February 27, 2017
Last Verified: January 2017

Keywords provided by Lawrence (Rusty) Hofmann, Stanford University:
Post Thrombotic Syndrome
Venous Stasis
Venous Occlusions
Venous Stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Thrombosis
Venous Thrombosis
Pathological Conditions, Anatomical
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action