Recruiting

EDPADEndovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease

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What is being tested

endovascular denervation

+ PTA

Device
Who is being recruted

From 18 to 75 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2022
See protocol details

Summary

Principal SponsorZhongda Hospital
Study ContactGao-Jun Teng, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 25, 2022

Actual date on which the first participant was enrolled.

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 TitleEndovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
NCT05345431
Principal SponsorZhongda Hospital
Study ContactGao-Jun Teng, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
eligible subjects aged 18-75 years,
clinically confirmed PAD patients in Rutherford category II-VI.
9 exclusion criteria prevent from participating
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,
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation.

Group II

Treating with balloon dilation or stent implantation only,

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Zhongda Hospital, Southeast University

Nanjing, ChinaOpen Zhongda Hospital, Southeast University in Google Maps
Recruiting
One Study Center