Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- limb salvage rate
研究概览
简要总结
This study is a multicenter, prospective, observational study, aiming to enroll 400 patients with peripheral arterial disease in the femoral-popliteal segment implanted with Eluvia stent. Each patient was followed up for 2 years. The technical success rate, target lesion patency rate, quality of life improvement, cost of Eluvia stent implantation, and other outcomes will be analysed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rutherford Stage 2-
- •At least 90% stenosis or occlusion of the femoropopliteal artery.
- •Eluvia stents are used for target lesions.
- •Agree and sign the informed consent form
排除标准
- •Life expectancy is less than 1 year.
- •Those with severe infection and gangrene of the limbs or those with tissue defects beyond the plane of the toes (ie major tissue loss), who may undergo major amputation even if the blood vessels are opened.
- •Patients and their families are reluctant to join the observational study, or have difficulty in communication and are unable to assess the quality of life.
- •Patients with in-stent restenosis of the femoral popliteal artery.
- •Patients with acute arterial thrombosis.
结局指标
主要结局
limb salvage rate
时间窗: 24 months
Proportion of patients without ambutation
The change of Rutherfor classification
时间窗: 24 months
Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months
F-TLR
时间窗: 24 months
free of target vascular reconstruction
次要结局
- mortality rate(24 months)
- Wound Healing Evaluation(24 months)
- the patency target lesion(24 months)
- Economics Evaluation(24 months)
- Technical success rate(1 month)
- the life quality change(24 months)
研究者
Ziheng Wu, MD
Associated chief physician
First Affiliated Hospital of Zhejiang University