The Safety and Efficacy of Drug Eluting Peripheral Vascular Stent System for the Treatment of Superficial Femoral Artery Stenosis and /or Occlusion: a Multi-center Stratified Randomized Single- Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- primary patency rate at 12 months after operation
研究概览
简要总结
Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.
详细描述
This is a prospective, multicenter, randomized study designed to enroll 138 patients with superficial femoral artery stenosis and /or occlusion who will be randomized 1:1 to be treated with the Drug eluting peripheral vascular stent system versus the commercially available Nitinol Stent System (Cordis Corporation). Patients will receive Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging at 6th month and 12th month post procedure. Clinical visits are scheduled at 0~30 days, 6 months, 12 months, and telephone visits are scheduled at 1 month, 3months, and 9 months. Furthermore, CDU will also be performed at baseline in all participants of the study.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •in Preoperative:
- •Aged from 18 to 85 years old, male or female
- •Subject's target lesions were stenosis and/or occlusion
- •Subject is aware of the study content, showing sufficient compliance with the research protocol and sign the Informed Consent
排除标准
- •in Preoperative:
- •In-Stent Restenosis(IRS) or restenosis after drug-eluting balloon administration
- •Serum creatinine concentration of the subject is higher than 1.5 times of the upper limit of normal serum creatinine concentration
- •Subject with coagulation abnormalities should not be performed
结局指标
主要结局
primary patency rate at 12 months after operation
时间窗: 12 months
the rate of the target lesion diameter stenosis \<50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 12 months postoperatively
次要结局
- primary patency rate at 6 months after operation(6 months)
- Stent fracture rate(6 months、12 months)
- target lesion revascularization rate(Preoperative，up to 1 month，6 months，12 months)