Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions: the SAFARI Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Freedom of major adverse events (MAEs)
研究概览
简要总结
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
详细描述
One hundred twenty patients with lesion lengths longer than 15 cm will be included. Patients will be invited for a follow-up visit at 1, 6, 12, and 24-month post-procedure. The primary effectiveness endpoint of the study is the primary patency at 12 months. The primary safety endpoint is freedom of major adverse events (MAEs) at 12 months. Secondary endpoints include acute procedure success rate; primary patency rate at 1, 6, and 24 months; freedom from TLR at 1-, 6-, 12, and 24-month follow-up; primary and secondary sustained clinical improvements at 1-, 6-, 12- and 24-month follow-up; Freedom of MAEs at 1-, 6-,12- and 24- month follow-up; change of quality of life at 1-, 6-,12- and 24- month follow-up.
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
- •The patient presented a score from 2 to 5 following Rutherford classification
- •The patient is willing to comply with specified follow-up evaluations at the specified times
- •The patient is >18 years old
- •Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
- •The patient has a projected life expectancy of at least 24 months
- •Before enrolment, the guidewire has crossed the target lesion
- •Target lesion length ≧150mm by angiographic estimation
- •Stenosis > 50% or occlusion in the femoropopliteal artery
- •There is angiographic evidence of patent distal popliteal artery and at least one distal runoff to the foot
排除标准
- •Previous bypass surgery or stenting in the target vessel
- •Patients who exhibit acute intraluminal thrombus at the target lesion vessel
- •Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
- •Pregnant women or Female patients with potential childbearing
- •Use of thrombectomy, atherectomy, or laser devices during the procedure
- •Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion
- •The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
- •Significant renal dysfunction (Serum creatinine >2.0mg/dl)
- •Patient with Known allergy to contrast media
结局指标
主要结局
Freedom of major adverse events (MAEs)
时间窗: 12-month
Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.
Primary patency
时间窗: 12-month
Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ≧2.5).
次要结局
- Freedom from clinically directed target lesion revascularization(24-month)
- Acute procedure success(72-hour within procedure)
- Primary patency(24-month)
- Freedom of major adverse events (MAEs)(24-month)
- Primary sustained clinical improvement(24-month)
- Vasc quality of life score(24-month)