Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- 12-month Primary Patency Rate
研究概览
简要总结
This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions.
详细描述
Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the endovascular debulking combined drug-coated balloon group and balloon dilatation combined with stent angioplasty group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments. At the same time, the peri-operative related factors that may affect the end point events, such as preoperative baseline data, lesion characteristics, imaging features, stent fracture, and end point observation indexes were analyzed by regression analysis.
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
- •1.all patients signed an informed consent form; 2.digital subtraction angiography (DSA) revealed femoropopliteal artery stenosis above 70% or occlusion resulting in claudication (Rutherford clinical category-Becker class II-III2-3) or critical limb ischemia (CLI) (Rutherford clinical category 4-5-Becker class IV-V) 3.with unobstructed vascular inflow; 4.with at least a vessel runoff;
- •good compliance and regular follow-up.
排除标准
- •Acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.;
- •Severe calcified lesions （grade 4 in the PACSS scale）;
- •In-stent restenosis lesion or surgical arterial bypass grafting;
- •Severe renal insufficiency: creatinine level greater than 2.5 mg/dL;
- •Platelet count below 100,000/μL or with antiplatelet / anticoagulation contraindications;
- •Immunologic diseases or malignant diseases;
- •Ongoing active infection;
- •Decompensated congestive heart failure or acute coronary syndrome;
- •Refuse to sign the informed consent Unwillingness to comply with follow-up suggestions.
研究组 & 干预措施
Intervention: balloon and Stents
plain balloon and Stents group
干预措施: balloon and Stent (Device)
Intervention: debulking and drug coated balloon
debulking and drug coated balloon group
干预措施: endovascular debulking and DCB (Device)
结局指标
主要结局
12-month Primary Patency Rate
时间窗: 12 months
systolic velocity ratio \>2.4 as measured by Duplex ultrasound.
次要结局
- Major Adverse Events at 12-month Post Procedure(12 months)
- 12-month Limb Salvage Rate(12 months)
- Technical success rate(1 day)
- freedom from clinically-driven TLR rate(12 months)