Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease (EDPAD)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    54
  • sponsor
    Zhongda Hospital
Updated on 11 May 2022

Summary

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.

Description

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.

Details
Condition PAD
Treatment PTA, endovascular denervation
Clinical Study IdentifierNCT05345431
SponsorZhongda Hospital
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

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
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