Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease (ED-PAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change of Ankle Brachial Index (ABI) at 6-month Post-procedure.
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 in the lower extremities,
- •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 last 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
Change of Ankle Brachial Index (ABI) at 6-month Post-procedure.
时间窗: From baseline to 6 months post procedure
The change value was using the ankle brachial index (ABI) at 6-month post-procedure minus the baseline ABI in two group. (the group which have higher change value mean the better result). "Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease.
次要结局
- NRS Score(At 1 week post procedure)
- Change of Transcutaneous Oxygen Pressure (TcPO2)(From baseline to 1 week post procedure)
- Change of Ankle Brachial Index (ABI) at 1-week Post-procedure.(From baseline to 1 week post procedure)
- Change of Ankle Brachial Index (ABI) at 3-month Post-procedure.(From baseline to 3 months post procedure)
- Rutherford Category(At 1 week post procedure)
- Number of Participants With MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)(From baseline to 6 months)
研究者
Gao-jun Teng
Clinical Professor
Zhongda Hospital