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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The control group | Other | Treating with balloon dilation or stent implantation only, |
|
| The EDN group | Experimental | Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endovascular denervation | Device | Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemia relief | Changes of the ankle brachial index(ABI) | from baseline to 6 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemia relief | Changes of the ankle brachial index(ABI) | from baseline to 3 months after procedure |
| clinical benefit | Changes of the Rutherford category(Rutherford category includes a total of 0-6 grades, the lower the grade, the better the results) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gao-Jun Teng, MD | Contact | +86 25 83272121 | gjteng@seu.edu.cn | |
| Guo-Feng Zhao, MD | Contact | +86-15951804797 | dreamboyseu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao-Jun Teng, MD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, Southeast University | Recruiting | Nanjing | Jiangsu | China |
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| PTA | Device | Treating with balloon dilation or stent implantation |
|
| from baseline to 3, 6 months after procedure |
| pain relief | Changes of the numeric rating scale ( NRS) scores(NRS scores includes a total of 0-10 grades, the lower the grade, the better the results) | from baseline to 3 ,6 months after procedure |