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临床试验/NCT05575245
NCT05575245撤回不适用

Clinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家开始时间: 2022年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
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 Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions.

详细描述

Prospective randomized controlled study to evaluate the difference of safety,effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the Excimer Laser Ablation Combined Drug-coated Balloon group and drug-eluting stent 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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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