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

Primary Purpose

PAD

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endovascular denervation
PTA
Sponsored by
Zhongda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PAD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. eligible subjects aged 18-75 years,
  2. clinically confirmed PAD patients in Rutherford category II-VI.

Exclusion Criteria:

  1. thrombolytic therapy performed within 30 days,
  2. patients who had undergone vascular bypass surgery before this study,
  3. allergy or contraindication of antiplatelet drugs, anticoagulants, thrombolytic drugs and contrast agents,
  4. patients with obvious bleeding tendency, coagulation dysfunction, hypercoagulability and blood system diseases,
  5. serious liver and kidney diseases,
  6. history of hemorrhagic stroke within the last 1 month or ischemic stroke or transient ischemic attack within 2 weeks,
  7. pacemaker implants,
  8. patients who are pregnant, breast-feeding or planning pregnancy,
  9. expected survival < 24 months.

Sites / Locations

  • Zhongda Hospital, Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

The control group

The EDN group

Arm Description

Treating with balloon dilation or stent implantation only,

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

Outcomes

Primary Outcome Measures

Ischemia relief
Changes of the ankle brachial index(ABI)

Secondary Outcome Measures

Ischemia relief
Changes of the ankle brachial index(ABI)
clinical benefit
Changes of the Rutherford category(Rutherford category includes a total of 0-6 grades, the lower the grade, the better the results)
pain relief
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)

Full Information

First Posted
April 12, 2022
Last Updated
April 20, 2022
Sponsor
Zhongda Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05345431
Brief Title
Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
Acronym
EDPAD
Official Title
Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The control group
Arm Type
Other
Arm Description
Treating with balloon dilation or stent implantation only,
Arm Title
The EDN group
Arm Type
Experimental
Arm Description
Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation.
Intervention Type
Device
Intervention Name(s)
endovascular denervation
Intervention Description
Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation
Intervention Type
Device
Intervention Name(s)
PTA
Intervention Description
Treating with balloon dilation or stent implantation
Primary Outcome Measure Information:
Title
Ischemia relief
Description
Changes of the ankle brachial index(ABI)
Time Frame
from baseline to 6 months after procedure
Secondary Outcome Measure Information:
Title
Ischemia relief
Description
Changes of the ankle brachial index(ABI)
Time Frame
from baseline to 3 months after procedure
Title
clinical benefit
Description
Changes of the Rutherford category(Rutherford category includes a total of 0-6 grades, the lower the grade, the better the results)
Time Frame
from baseline to 3, 6 months after procedure
Title
pain relief
Description
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)
Time Frame
from baseline to 3 ,6 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gao-Jun Teng, MD
Phone
+86 25 83272121
Email
gjteng@seu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-Feng Zhao, MD
Phone
+86-15951804797
Email
dreamboyseu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, MD
Organizational Affiliation
Zhongda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease

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