Endovascular Denervation in Patients With Peripheral Arterial Disease

Sponsor

Zhongda Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04060797

Collaborator

(none)

Enrollment

Location

Arm

48.6

Anticipated Duration (Months)

0.4

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	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 :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Endovascular Denervation in Patients With Peripheral Arterial Disease

Anticipated Study Start Date :

Aug 13, 2019

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: endovascular denervation endovascular denervation	Device: endovascular denervation multi-electrode catheter-based endovascular denervation

Arm

Intervention/Treatment

Experimental: endovascular denervation

endovascular denervation

Device: endovascular denervation

multi-electrode catheter-based endovascular denervation

Outcome Measures

Primary Outcome Measures

Ischemia relief [from baseline to 1 months after procedure]
Changes of the ankle brachial index(ABI)

Secondary Outcome Measures

Ischemia relief [from baseline to 3months after procedure]
Changes of the ankle brachial index(ABI)
pain relief [from baseline to 3 months after procedure]
Changes of the numeric rating scale ( NRS) scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongda Hospital, Southeast University	Nanjing	Jiangsu	China	210009

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:

NCT04060797

Other Study ID Numbers:

ED-PAD

First Posted:

Aug 19, 2019

Last Update Posted:

Aug 19, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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 Aug 19, 2019