Excellent：Clinical Study of Excimer Laser and Drug Coated Balloon Versus Excimer Laser and Plain Balloon Versus Plain Balloon and Drug Coated Balloon to Treat Femoropopliteal In-stent Restenosis
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Primary Patency Rate
研究概览
简要总结
This is a randomized study comparing Excimer laser and drug coated balloon Versus Excimer laser and plain balloon versus plain balloon and drug coated balloon to Treat femoropopliteal in-stent restenosis
详细描述
This is a randomized study comparing Excimer laser and drug coated balloon Versus Excimer laser and plain balloon versus plain balloon and drug coated balloon to Treat femoropopliteal in-stent restenosis
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial In-stent restenosis Disease located within the femoropopliteal artery Patient has a In-stent restenosis lesion(s) with >50% stenosis documented angiographically Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
排除标准
- •They were excluded if they had one or more of the following:
- •Acute or subacute lower limb ischemia;
- •Severe calcification lesions;
- •Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization
- •untreated ipsilateral iliac artery stenosis>70%, or the distal runoff artery <1 root;
- •Previously lower extremity intervention or surgical graft artery bypass;
- •Severe renal insufficiency, creatinine level greater than 2.5 mg/dL;
- •The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications;
- •Patients with immune system diseases or malignant tumours;
- •ongoing active infection
- •decompensated congestive heart failure or acute coronary syndrome;
- •Unwillingness to return for future follow-up visits
结局指标
主要结局
Primary Patency Rate
时间窗: 12 months
Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis \>50% with a peak systolic velocity ratio \>2.4 as measured by Duplex ultrasound.
次要结局
- Technical success(1 day)
- Limb Salvage Rate(12 months)
- freedom from clinically-driven TLR(12 months)
- Major Adverse Events(12 months)