Back to resultsEndovascular Denervation in Patients With Peripheral Arterial Disease
Primary Purpose
PAD
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endovascular denervation
Sponsored by
About this trial
This is an interventional treatment trial for PAD
Eligibility Criteria
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
Sites / Locations
- Zhongda Hospital, Southeast UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
endovascular denervation
Arm Description
endovascular denervation
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)
pain relief
Changes of the numeric rating scale ( NRS) scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04060797
Brief Title
Endovascular Denervation in Patients With Peripheral Arterial Disease
Official Title
Endovascular Denervation in Patients With Peripheral Arterial Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 13, 2019 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endovascular denervation
Arm Type
Experimental
Arm Description
endovascular denervation
Intervention Type
Device
Intervention Name(s)
endovascular denervation
Intervention Description
multi-electrode catheter-based endovascular denervation
Primary Outcome Measure Information:
Title
Ischemia relief
Description
Changes of the ankle brachial index(ABI)
Time Frame
from baseline to 1 months after procedure
Secondary Outcome Measure Information:
Title
Ischemia relief
Description
Changes of the ankle brachial index(ABI)
Time Frame
from baseline to 3months after procedure
Title
pain relief
Description
Changes of the numeric rating scale ( NRS) scores
Time Frame
from baseline to 3 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:
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
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
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, MD
Phone
+86 25 83272121
Email
gjteng@seu.edu.cn
First Name & Middle Initial & Last Name & Degree
Guo-Feng Zhao, MD
Phone
+86-15951804797
Email
dreamboyseu@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endovascular Denervation in Patients With Peripheral Arterial Disease
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