GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion (>8cm) Superficial Femoral Artery Occlusive Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 30
- 主要终点
- Efficacy: Primary Patency at Three Years
研究概览
简要总结
To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.
详细描述
This is a multicenter, prospective, randomized study with clinical and radiographic follow-up for three years post-procedure. Approximately one hundred fifty subjects will be enrolled and randomized into one of two study treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lifestyle-limiting claudication or rest pain.
- •Subject (or their legal guardian) has read, understood and provided written informed consent.
- •At least 21 years of age.
- •Quality of life questionnaires completed.
- •Noninvasive lower extremity arterial studies within 45-days prior to study procedure.
- •If applicable, staged ipsilateral vascular procedure ≥ 14-days prior to study procedure.
- •If applicable, vascular treatment on non-study leg for bilateral claudication ≥ 14-days prior to study procedure.
- •Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test.
- •Projected life expectancy of greater than three years.
- •The ability to comply with protocol.
- •Angiographic and Lesion Requirements meets protocol criteria.
排除标准
- •Untreated flow-limiting aortoiliac occlusive disease.
- •Any previous stenting or surgery in the target vessel.
- •Subjects with arterial lesions requiring treatment with device diameters other than 6, 7, or 8 mm.
- •Severe ipsilateral common femoral/profunda disease requiring surgical intervention.
- •Femoral or popliteal aneurysm.
- •Non-atherosclerotic disease resulting in occlusion.
- •Tibial artery disease requiring treatment.
- •Prior ipsilateral femoral artery bypass.
- •Severe medical comorbidities.
- •Popliteal artery vascular access at any time during procedure.
- •Antegrade and retrograde vascular access on the same common femoral artery at the time of the SFA intervention.
- •Serum creatinine > 2.5 mg/dL within 45 days prior to study procedure.
- •Major distal amputation.
- •Septicemia.
- •Any previously known coagulation disorder.
- •Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion).
- •Contraindication to anticoagulation or antiplatelet therapy.
- •Known allergies to stent/stent-graft components.
- •History of prior life-threatening reaction to contrast agent.
- •Currently participating in another clinical research trial.
- •Current peritoneal or hemodialysis.
结局指标
主要结局
Efficacy: Primary Patency at Three Years
时间窗: 3 years
Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention. The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end of the study (three years).
Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)
时间窗: 30 days
Major procedural events include death, myocardial infarction, acute renal insufficiency, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion. The results for this outcome measure are the total percent of these events that occurred in each treatment arm within the first 30 days following stent implantations.
次要结局
- Primary Assisted Patency(3 years)
- Secondary Patency(3 years)
- Technical Success at Initial Procedure(Time of implant procedure)
- Target Vessel Revascularization (TVR)(3 years)
- Target Lesion Revascularization (TLR)(3 years)
- Improvement in Rutherford Classification (Clinical Success)(3 years)
- Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)(3 years)
- Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)(3 years)
- Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)(3 years)
- Change in Ankle-Brachial Index (ABI)(3 years)
- Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)(3 years)
- Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)(3 years)
- Occurrence of Stent Fracture(3 years)