Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Stanford University
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Stent Migration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Stent Migration
Time Frame: up to one year following the procedure 1 year
Stent migration is reported as the count of participants with stent migration within 1 year following stent placement.
Primary Patency Rate
Time Frame: up to 1 year following the procedure
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.
Secondary Outcomes
- Decrease in Swelling of Affected Extremity(up to 2 years)
- 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)
- Venous Clinical Severity Score(up to 2 years)
- VEINS-QOL(Up to 2 years)
- Villalta PTS Scale(up to 2 years)
Investigators
Lawrence (Rusty) Hofmann
Chief of Interventional Radiology
Stanford University