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

July 22, 2011
September 17, 2013
December 2010
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01406795 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Thrombosis
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.
Experimental: Venous Stent Arm
The study is a single treatment arm study and the venous stent will be placed in all eligible participants.
Intervention: Device: Gore Viabahn Heparin Coated Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Fizaa Ahmed (650)725-6409 fizaa@stanford.edu
Contact: Alison Holzer, Ph.D. 650-736-0959 aholzer@stanfordmed.org
United States
 
NCT01406795
SU-01312011-7377, FDA IDE - G090054, IRB eProtocol - 14781, SPO # 49275
Not Provided
Lawrence (Rusty) Hofmann, Stanford University
Stanford University
Not Provided
Principal Investigator: Dr. Lawrence (Rusty) Hofmann MD Stanford University
Stanford University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP