A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety Between Sirolimus Coated Balloon Catheter and Paclitaxel Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 1
- 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 Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis
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
- •SFA and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion.
- •The length of target lesion less than 20 cm
- •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
- •There are more than 2 lesion need to treat in the target vessel.
- •The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
- •The target lesion had residual stenosis>30% or flow-limit dissection after pre-dilatation.
- •The patient had outflow less than 1 vessel
- •The lesion located in a stent.
- •Patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus 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.
- •The investigator think the patient is not suitable for participation in the clinical trial.
研究组 & 干预措施
Sirolimus-eluting balloon angioplasty
Using Sirolimus Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
干预措施: Sirolimus-eluting balloon catheter (Device)
Paclitaxel-eluting balloon angioplasty
Using Paclitaxel Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
干预措施: Paclitaxel-eluting balloon catheter (Device)
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
- The change of Rutherford class from baseline(12 months post-procedure)
- Rate of clinically driven target lesion revascularization (CD-TLR) at 12 months post-procedure(12 months post-procedure)
- Rate of device success(immediate post-procedure)
- The change of ankle-brachial index (ABI) from baseline(12 months post-procedure)
- Rate of composite safety endpoint(30 days post-procedure)