NCT02825446终止不适用
A Pilot Prospective Study of Two Methods of Revascularization of Tibial Arteries: Angioplasty Tibial Arteries, and Angioplasty Tibial Artery, Augmented by Radio Frequency Denervation Popliteal Artery in Patients With Steno-occlusive Lesion of the Tibial Arteries
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- the absence of thrombosis or stenosis of the popliteal artery
研究概览
简要总结
Angioplasty augmented radiofrequency denervation popliteal artery, in our opinion, will remove the spasm with macro and microcirculatory blood flow, which increases revascularization patency of tibial arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic lower limb ischemia 3-6 degree by Rutherford;
- •Stenosis or occlusion of no more than 2 tibial arteries;
- •Stenosis of the tibial arteries more than 70 %;
- •Duration stenosis or occlusion no more than 70 mm;
排除标准
- •Diabetes mellitus type 2
- •Occlusion or stenosis of all tibial arteries
- •Expressed calcification of tibial arteries angioplasty tolerant
- •Hemodynamically significant stenosis of the popliteal artery;
- •Chronic heart failure of III-IV functional class by 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;
- •Patient refusal to participate or continue to participate in the study;
结局指标
主要结局
the absence of thrombosis or stenosis of the popliteal artery
时间窗: 12 mounth after intervention
during the whole period of observation, confirmation of patency of the arterial ultrasound of the operated segment as well as such parameters as flow rate, presence of stenosis (%) or thrombosis
次要结局
- Primary patency after intervention(12-mounth after intervention)
- Secondary patency after intervention(12-mounth after intervention)
- Number of participants with limb salvage(12 mounth after intervention)
- Laser Doppler Flowmetry(12 mounth after intervention)
- Transcutaneous oxygen tension(12 mounth after intervention)
研究者
研究点 (2)
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