NCT03142347Unknown不适用
Remote Endarterectomy vs Remote Endarterectomy Supplement DCB Balloon Angioplasty in Patients With the Femoral Artery Occlusive Disease (TASCII D)
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- the change of lumen in target vessel
研究概览
简要总结
Comparison effectiveness two methods revascularization of the superficial femoral artery: remote endarterectomy vs. remote endarterectomy supplemented DCB angioplasty in patients with steno-occlusive lesion of the femoro-popliteal segment of TASCII D
详细描述
Given that more and more devices appear to deliver cytotoxic drugs into the depth of atherosclerotic plaque, it is interesting to study the effect of these drugs when applied directly after plaque removal.
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with occlusive lesions of C and D type femoral artery and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford)
- •Patients who consented to participate in this study.
排除标准
- •Chronic heart failure of III-IV functional class by New York Heart Association (NYHA) classification.
- •Decompensated chronic "pulmonary" heart
- •Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min);
- •Polyvalent drug allergy
- •Cancer in the terminal stage with a life expectancy less than 6 months;
- •Acute ischemic
- •Expressed aortic calcification tolerant to remote endarterectomy
- •Patient refusal to participate or continue to participate in the study
结局指标
主要结局
the change of lumen in target vessel
时间窗: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
stenosis or occlusions
次要结局
- Number of participants with complications in long-term period after the operation.(3 days after the operation, 6 month, 12 month, 2 years)
- Vessel wall thickness(3 days after the operation, 6 month, 12 month, 2 years)
- Number of participants with limb salvage(3 days after the operation, 6 month, 12 month, 2 years)
研究者
研究点 (2)
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