Endovascular Denervation in Patients With Peripheral Arterial Disease

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    20
  • sponsor
    Zhongda Hospital
Updated on 24 January 2021

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 peripheral arterial disease, Peripheral Arterial Disease (PAD), Peripheral Arterial Disease (PAD), peripheral arterial diseases, peripheral artery disease
Treatment endovascular denervation
Clinical Study IdentifierNCT04060797
SponsorZhongda Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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