Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease

Conditions
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PAD

Intervention / Treatment
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* Device: endovascular denervation
* Device: PTA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: eligible subjects aged 18-75 years, clinically confirmed PAD patients in Rutherford category II-VI. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The control group<br>Treating with balloon dilation or stent implantation only, | Device: PTA<br>* Treating with balloon dilation or stent implantation<br>|
| Experimental: The EDN group<br>Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. | Device: endovascular denervation<br>* Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia relief | Changes of the ankle brachial index(ABI) | from baseline to 6 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |