Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Stent Migration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Stent Migration
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Lawrence (Rusty) Hofmann
Chief of Interventional Radiology
Stanford University