Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Ischemia relief
研究概览
简要总结
Sympathetic overactivity partly promotes the development of peripheral artery disease which mainly leads to ischemia of the lower limbs. Endovascular arterial denervation (ED) is a minimally invasive technique which could deliver Radiofrequency energy by a multi-electrode catheter to the Lower limb artery to restore Sympathetic activity. The purpose of this study is to evaluate the effects of multi-electrode radiofrequency ablation system on lower limb ischemia with PAD.
详细描述
Peripheral arterial disease(PAD) show insufficient blood supply of diseased limbs, which causes intermittent claudication of lower limbs, reduced skin temperature, pain, and chronic progressive disease that still produces ulcer or necrosis. Some clinical studies have shown Sympathetic overactivity in the lower arterial ischemic disease. The multi-electrode radiofrequency ablation system can significantly reduce the excitability of sympathetic nerve, restore the normal response of sympathetic nerve, relieve the pain and discomfort of patients, effectively improve the symptoms of lower limb ischemia, and improve the quality of life of patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eligible subjects aged 18-75 years,
- •clinically confirmed PAD patients in Rutherford category II-VI.
排除标准
- •thrombolytic therapy performed within 30 days,
- •patients who had undergone vascular bypass surgery before this study,
- •allergy or contraindication of antiplatelet drugs, anticoagulants, thrombolytic drugs and contrast agents,
- •patients with obvious bleeding tendency, coagulation dysfunction, hypercoagulability and blood system diseases,
- •serious liver and kidney diseases,
- •history of hemorrhagic stroke within the last 1 month or ischemic stroke or transient ischemic attack within 2 weeks,
- •pacemaker implants,
- •patients who are pregnant, breast-feeding or planning pregnancy,
- •expected survival < 24 months.
结局指标
主要结局
Ischemia relief
时间窗: from baseline to 6 months after procedure
Changes of the ankle brachial index(ABI)
次要结局
- clinical benefit(from baseline to 3, 6 months after procedure)
- Ischemia relief(from baseline to 3 months after procedure)
- pain relief(from baseline to 3 ,6 months after procedure)
研究者
Gao-jun Teng
Clinical Professor
Zhongda Hospital