NCT05246410招募中不适用
A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Spot Stent System Using in the Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- The primary patency rate of target lesion at 12 months post-procedure
研究概览
简要总结
A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.
详细描述
The objective of this clinical investigation is to assess the efficacy and safety of spot stent system ,which is indicated for use in patients with atherosclerotic disease of the superficial femoral artery (SFA) or proximal popliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty.
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
- •Age ≥18 years old and ≤80 years old
- •Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
- •Target lesion is in the superficial femoral artery (SFA) and/or proximal popliteal artery (above the knee), located ≥1 cm below the common femoral artery (CFA) bifurcation to the distal segment of the proximal popliteal artery at the superior end of the patella.
- •Target lesion had severe stenosis (stenosis degree ≥70%) or occlusion.
- •Presence of at least one patent infrapopliteal vessel.
- •The length of target lesion ≥10 cm.
- •After predilation, the target lesion has <30% residual stenosis and presence of at least one flow-limiting dissection (by visual estimate).
- •Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed.
排除标准
- •The plasma creatinine level is higher than 150 umol/L.
- •Thrombolysis or thrombectomy is required.
- •The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
- •Previously implanted stent in the target lesion.
- •The guide wire can not cross the target lesion.
- •Angiographic evidence of calcification severe enough that it renders the target lesion non-dilatable.
- •Patient has a known allergy to anticoagulant drugs, anti-platelet drugs or contrast medium that cannot be adequately pre-medicated.
- •Women who are pregnant or breast-feeding.
- •The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
- •Patient has life expectancy of less than 12 months.
- •Patient who planned to do above the ankle amputation before the operation.
- •Patient who had severe hemorrhage or coagulation disorder which judged by the investigator.
- •The investigator think the patient is not suitable for participation in the clinical trial.
结局指标
主要结局
The primary patency rate of target lesion at 12 months post-procedure
时间窗: 12 months post-procedure
Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4)
次要结局
- Rate of device success(immediate post-procedure)
- Rate of procedural success(7 days post-procedure)
- Rate of clinically driven target lesion revascularization within 12 months post-procedure(12 months post-procedure)
- The change of Rutherford class from baseline(12 months post-procedure)
- The change of ankle-brachial index (ABI) from baseline(12 months post-procedure)
- Rate of composite safety endpoint(30 days post-procedure)
研究者
研究点 (2)
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