Endovascular Denervation in 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 in Patients With Peripheral Arterial Disease

Conditions
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PAD

Intervention / Treatment
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* Device: endovascular denervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 75 years Patients with established PAD with Rutherford Grade2-6 Exclusion Criteria: pregnant or intent to become pregnant Orthostatic hypotension acute or severe systemic infection uncorrected coagulation dysfunction renal dysfunction Patients that have allergy to contrast agent and nitinol Myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion Cerebrovascular accidents and alimentary tract hemorrhage within 3 months before inclusion participants who are not suitable to be enrolled into the study assessed bythe researchers

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endovascular denervation<br>endovascular denervation | Device: endovascular denervation<br>* multi-electrode catheter-based endovascular denervation<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 1 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia relief | Changes of the ankle brachial index(ABI) | from baseline to 3months after procedure | 
| pain relief | Changes of the numeric rating scale ( NRS) scores | from baseline to 3 months after procedure |