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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Lawrence (Rusty) Hofmann, Stanford University
ClinicalTrials.gov Identifier:
NCT01406795
First received: July 22, 2011
Last updated: September 17, 2013
Last verified: September 2013
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Stanford University:

Primary Outcome Measures:
  • Stent Migration or Stent Fracture [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Stent Migration or Stent Fracture [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Primary patency rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Freedom from device-related amputation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Assisted-primary patency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Secondary patency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Decrease in swelling of affected extremity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Venous Clinical Severity Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • VEINS-QOL [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Villalta PTS Scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: December 2010
Estimated Study Completion Date: June 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406795

Contacts
Contact: Fizaa Ahmed (650)725-6409 fizaa@stanford.edu
Contact: Alison Holzer, Ph.D. 650-736-0959 aholzer@stanfordmed.org

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Kamil Unver    650-725-9810    kunver@stanfordmed.org   
Principal Investigator: Dr. Lawrence (Rusty) Hofmann MD         
Sub-Investigator: Stanley G Rockson         
Sub-Investigator: Haruka Itakura         
Sub-Investigator: Dr. John D Louie         
Sub-Investigator: Gloria Hwang         
Sub-Investigator: Nishita N. Kothary         
Sub-Investigator: William T Kuo MD         
Sub-Investigator: David Hovsepian         
Sub-Investigator: Daniel Yung-Ho Sze         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Lawrence (Rusty) Hofmann MD Stanford University
  More Information

No publications provided

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
Study First Received: July 22, 2011
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Stanford University:
Post Thrombotic Syndrome
Venous Stasis
Venous Occlusions
Venous Stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Pathological Conditions, Anatomical
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 01, 2014