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

NCT01406795 | Terminated Results

• 4 other identifiers: SU-01312011-7377FDA IDE - G090054IRB eProtocol - 14781SPO # 49275
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

Post Thrombotic Syndrome; Venous Stasis; Venous Occlusions; Venous Stenosis

Outcome Measures

Primary Outcomes (3)

• Stent Migration

  Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.

  up to 1 month following the procedure

• Stent Migration

  Stent migration is reported as the count of participants with stent migration within 1 year following stent placement.

  up to one year following the procedure 1 year

• Primary Patency Rate

  Patency refers to whether the stent is unoccluded (open). Primary patency rate was defined as the count of participants with \>= 50% patency following initial stent placement, and is reported as the count of participants meeting this criteria.

  up to 1 year following the procedure

Secondary Outcomes (8)

• Freedom From Device-related Amputation

  up to 1 year following the procedure

• Assisted-primary Patency

  up to 1 year

• Secondary Patency

  up to 1 year

• Adverse Events

  up to two years 2 years

• Decrease in Swelling of Affected Extremity

  up to 2 years

Study Arms (1)

Venous Stent Arm

EXPERIMENTAL

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

Interventions

Gore Viabahn Heparin Coated Stent 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.

Venous Stent Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is at least 18 years old
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome; Varicose Ulcer

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The study was underpowered, enrolling only a single patient (goal enrollment was 15 patients).

Results Point of Contact

• Title: Rusty Hofmann
• Organization: Stanford University

lhofmann@stanfordhealthcare.org

6507366096

Study Officials

• Dr. Lawrence (Rusty) Hofmann MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Interventional Radiology

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: August 1, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 27, 2017
• Results First Posted: February 27, 2017

Record last verified: 2017-01

Locations

US (1)