NCT05517291招募中不适用
Paclitaxel Coated Balloon Angioplasty Versus Primary Selective Stenting in the Treatment of TASC C/D Chronic Femoropopliteal Artery Occlusive Disease: A Multicenter Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- 1-year primary patency rate
研究概览
简要总结
This study aims to compare the mid- and long-term outcomes between paclitaxel-coated balloon and primary selective stenting in the treatment of TASC C/D femoropopliteal artery occlusive disease.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age 18-85yrs.
- •Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
- •Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
- •Rutherford category 2-
- •Subject has a de novo TASC C/D femoropopliteal artery lesions which does not exceed to the segment P1 of popliteal artery.
- •The total length of target lesion ≤30cm.
- •Reference vessel diameter >4 mm and <6.5 mm by visual assessment.
- •Patent inflow artery with stenosis <30% and at least 1 infrapopliteal artery to the ankle (<50% diameter stenosis).
- •A guidewire has successfully traversed the target treatment segment.
排除标准
- •Acute thrombus in the target vessels.
- •Vessel stenosis or occlusion due to Buerger's disease or autoimmune arteritis.
- •Subject received prior stents implantation with in-stent restenosis or occlusion.
- •Reintervention of the target lesion <90 days before the study procedure.
- •Acquired thrombophilia or uncontrolled hypercoagulation states.
- •Life expectancy <12 months.
- •Severe renal（SCr≥2.5 mg/dl）or hemodialysis dependence.
- •Pregnancy, suspected pregnancy, or breastfeeding during study period.
- •Contraindication to contrast media or any study-required medication (antiplatelet, anticoagulant, or thrombolytic agents, etc.).
- •Hypersensitivity to nitinol and/or paclitaxel.
结局指标
主要结局
1-year primary patency rate
时间窗: 1 year
次要结局
- clinical-driven target lesion revascularization(1, 2 and 3 years)
研究者
研究点 (2)
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