Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
Zhongda Hospital
54 participants
Apr 25, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- eligible subjects aged 18-75 years,
- clinically confirmed PAD patients in Rutherford category II-VI.
Exclusion Criteria9
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation
Treating with balloon dilation or stent implantation
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05345431