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

This study is currently recruiting participants.

Verified June 2012 by Stanford University

Sponsor:

Information provided by (Responsible Party):

Stanford University

ClinicalTrials.gov Identifier:

NCT01406795

First received: July 22, 2011

Last updated: June 6, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 22, 2011

Last Updated Date

June 6, 2012

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01406795 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Venous Thrombosis

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2015

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kamil Unver

(650) 725-9810

kunver@stanfordmed.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01406795

Other Study ID Numbers ^ICMJE

SU-01312011-7377, FDA IDE - G090054, IRB eProtocol - 14781, SPO # 49275

Has Data Monitoring Committee

Responsible Party

Stanford University

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Dr. Lawrence (Rusty) Hofmann MD

Stanford University

Information Provided By

Stanford University

Verification Date

June 2012

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

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