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

Sponsor

Zhongda Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05345431

Collaborator

(none)

Enrollment

Location

Arms

50.2

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
PAD	Device: endovascular denervation Device: PTA	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease

Anticipated Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: The control group Treating with balloon dilation or stent implantation only,	Device: PTA Treating with balloon dilation or stent implantation
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.	Device: endovascular denervation Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation

Arm

Intervention/Treatment

Other: The control group

Treating with balloon dilation or stent implantation only,

Device: PTA

Treating with balloon dilation or stent implantation

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.

Device: endovascular denervation

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

Outcome Measures

Primary Outcome Measures

Ischemia relief [from baseline to 6 months after procedure]
Changes of the ankle brachial index(ABI)

Secondary Outcome Measures

Ischemia relief [from baseline to 3 months after procedure]
Changes of the ankle brachial index(ABI)
clinical benefit [from baseline to 3, 6 months after procedure]
Changes of the Rutherford category(Rutherford category includes a total of 0-6 grades, the lower the grade, the better the results)
pain relief [from baseline to 3 ,6 months after procedure]
Changes of the numeric rating scale ( NRS) scores(NRS scores includes a total of 0-10 grades, the lower the grade, the better the results)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongda Hospital, Southeast University	Nanjing	Jiangsu	China

Sponsors and Collaborators

Zhongda Hospital

Investigators

Principal Investigator: Gao-Jun Teng, MD, Zhongda Hospital Southeast University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gao-jun Teng, Clinical Professor, Zhongda Hospital

ClinicalTrials.gov Identifier:

NCT05345431

Other Study ID Numbers:

EDN-PAD

First Posted:

Apr 25, 2022

Last Update Posted:

Apr 25, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Study Results

No Results Posted as of Apr 25, 2022