A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty for the Treatment of Superficial Femoral Artery Occlusions
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Primary patency.
研究概览
简要总结
The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.
详细描述
This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ nitinol self-expanding stent as compared to balloon angioplasty only. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.
The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, long de novo or restenotic occlusions (5 - 14.5 cm) on diagnostic imaging with a history of at least 6 months. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.
Trial participants will be randomized to the SMART™ nitinol self-expanding stent or to balloon angioplasty only.
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 at 8 investigational sites in The Netherlands.
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
- 30 Years 至 —（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 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 6 months
- •The patient should be suitable for percutaneous transluminal angioplasty (PTA) and also for stenting.
排除标准
- •Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft.
- •Patient having total occlusions or severe stenosis of the iliac artery on the same side must be excluded.
- •Gangrene in index limb (Rutherford category 6).
结局指标
主要结局
Primary patency.
时间窗: 12 months
次要结局
- Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography.(at deployment)
- Procedural success defined as successful recanalization, without the occurrence of a SAE.(up to the moment haemostasis has been achieved)
- Procedural complications, defined as any adverse event(from start of the procedure up to the moment haemostasis has been achieved)
- Ankle Brachial Index.(discharge and 12 months)
- Treadmill test.(12 months)
- Restenosis measured by Duplex Ultrasound.(12 months)
- Quality of Life assessment.(baseline, 6, and 12 months post procedure)