跳至主要内容
临床试验/NCT05158257
NCT05158257招募中不适用

Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2021年9月30日最近更新:
适应症

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

入选标准

  • 未提供

排除标准

  • 未提供

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

  • 12-month Limb Salvage Rate(12 months)
  • Major Adverse Events at 12-month Post Procedure(12 months)
  • Technical success rate(1 day)
  • freedom from clinically-driven TLR rate(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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