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

Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01406795
• Other study ID #: SU-01312011-7377
• Secondary ID: FDA IDE - G09005
• Status: Terminated
• Phase: N/A
• First received: July 22, 2011
• Last updated: April 26, 2016
• Start date: December 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent Migration or Stent Fracture		1 month	Yes
Primary	Stent Migration or Stent Fracture		1 year	Yes
Primary	Primary patency rate		1 year	No
Secondary	Freedom from device-related amputation		1 year	Yes
Secondary	Assisted-primary patency		1 year	No
Secondary	Secondary patency		1 year	No
Secondary	Adverse Events		2 years	Yes
Secondary	Decrease in swelling of affected extremity		2 years	No
Secondary	Venous Clinical Severity Score		2 years	No
Secondary	VEINS-QOL		2 years	No
Secondary	Villalta PTS Scale		2 years	No