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

NCT ID: NCT01406795

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Venous Thrombosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venous Stent Arm

The study is a single treatment arm study and the venous stent will be placed in all eligible participants.

Group Type: EXPERIMENTAL

Gore Viabahn Heparin Coated Stent

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Lawrence (Rusty) Hofmann

Chief of Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Lawrence (Rusty) Hofmann MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

FDA IDE - G090054

Identifier Type: -

Identifier Source: secondary_id

IRB eProtocol - 14781

Identifier Type: -

Identifier Source: secondary_id

SPO # 49275

Identifier Type: -

Identifier Source: secondary_id

SU-01312011-7377

Identifier Type: -

Identifier Source: org_study_id