A Clinical Investigation of the Cordis S.M.A.R.T. ™ CONTROL ™ Nitinol Stent System Versus the Bard® Luminexx™ 6F Vascular Stent for the Treatment of TASC C & D Superficial Femoral Artery Long Lesions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- primary patency detectable by duplex ultrasound through the index lesion
研究概览
简要总结
This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C & D superficial femoral artery long lesions (up to 22 cm) in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency rate at 6 and 12 months post procedure.
详细描述
This is a German multi-center prospective, randomized, two-arm study evaluating performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System as compared to the C.R. Bard® Luminexx™ 6F Vascular Stent. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 200 patients will be entered into the study.
The study population will consist of approximately 200 symptomatic peripheral vascular disease patients with TASC C & D SFA lesions. The disease will consist of symptomatic, long de novo or restenotic lesions (> 70% stenosis) and occlusions (5 - 22 cm) on diagnostic imaging. The lesion must not extend into the distal SFA and the popliteal artery. At least one distal popliteal artery must be patent as well as one calf vessel. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.
Trial participants will be randomized to the Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System or to the Bard® Luminexx™ 6F Vascular Stent.
Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure.
This study will be conducted over up to 15 investigational sites in Germany.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic leg ischemia by Rutherford classification (category 2, 3, 4 or 5); duration of intermittent claudication (category 2-3) should be at least 3 months.
- •One superficial femoral artery de novo or restenotic lesion (more than 70% stenosis or occlusions), with a lesion length of more than 5 to less than 22 cm.
- •Patent popliteal artery on the index side, i.e., single vessel runoff or better with at least one of three vessels patent to the lower 1/3 of the calf prior to the day of the procedure.
排除标准
- •Revascularisation involving the same limb within 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure.
- •Patients having total occlusions of the iliac artery on the same side must be excluded.
- •Previously implanted stent(s) in the to be treated artery at the same site.
- •Requiring stent placement in the distal superficial femoral artery and the popliteal artery.
结局指标
主要结局
primary patency detectable by duplex ultrasound through the index lesion
时间窗: 12 months
次要结局
- adverse events(baseline, discharge, 6 and 12 months post procedure)
- procedural success(up to removal of catheter sheath)
- binary restenosis(6 and 12 months)
- procedural complications(up to removal of catheter sheath)
- Ankle Brachial Index(discharge and 12 months)
- target lesion revascularisation(6 and 12 months)
- target vessel revascularisation(6 and 12 months)
- clinical categorization of chronic limb ischemia by means of the Rutherford classification(discharge, 6 and 12 months post procedure)
- technical success(time of deployment)
- stent fractures(6 and 12 months)
- primary patency(6 months)