Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• eligible subjects aged 18-75 years,
• clinically confirmed PAD patients in Rutherford category II-VI.
Locations
Other Locations
China
Zhongda Hospital, Southeast University
RECRUITING
Nanjing
Contact Information
Primary
Gao-Jun Teng, MD
gjteng@seu.edu.cn
+86 25 83272121
Backup
Guo-Feng Zhao, MD
dreamboyseu@163.com
+86-15951804797
Time Frame
Start Date: 2022-04-25
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 54
Treatments
Other: The control group
Treating with balloon dilation or stent implantation only,
Experimental: The EDN group
Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation.
Related Therapeutic Areas
Sponsors
Leads: Zhongda Hospital