Clinical trial NCT01406795: The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses
Official title: Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Venous Thrombosis
Keywords: Post Thrombotic Syndrome
Venous Stasis
Venous Occlusions
Venous Stenosis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Stent Migration
timeFrame: up to 1 month following the procedure
measure: Stent Migration
timeFrame: up to one year following the procedure 1 year
measure: Primary Patency Rate
timeFrame: up to 1 year following the procedure
Secondary outcomes:
measure: Freedom From Device-related Amputation
timeFrame: up to 1 year following the procedure
measure: Assisted-primary Patency
timeFrame: up to 1 year
measure: Secondary Patency
timeFrame: up to 1 year
measure: Adverse Events
timeFrame: up to two years 2 years
measure: Decrease in Swelling of Affected Extremity
timeFrame: up to 2 years
measure: Venous Clinical Severity Score
timeFrame: up to 2 years
measure: VEINS-QOL
timeFrame: Up to 2 years
measure: Villalta PTS Scale
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Lawrence (Rusty) Hofmann MD
role: PRINCIPAL_INVESTIGATOR
References: