Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
EDPAD
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedStudy Start
First participant enrolled
April 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedApril 25, 2022
April 1, 2022
3.2 years
April 12, 2022
April 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Ischemia relief
Changes of the ankle brachial index(ABI)
from baseline to 6 months after procedure
Secondary Outcomes (3)
Ischemia relief
from baseline to 3 months after procedure
clinical benefit
from baseline to 3, 6 months after procedure
pain relief
from baseline to 3 ,6 months after procedure
Study Arms (2)
The control group
OTHERTreating with balloon dilation or stent implantation only,
The EDN group
EXPERIMENTALTreating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation.
Interventions
Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation
Eligibility Criteria
You may qualify if:
- eligible subjects aged 18-75 years,
- clinically confirmed PAD patients in Rutherford category II-VI.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhongda Hospitallead
Study Sites (1)
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
Study Officials
- PRINCIPAL INVESTIGATOR
Gao-Jun Teng, MD
Zhongda Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
April 12, 2022
First Posted
April 25, 2022
Study Start
April 25, 2022
Primary Completion
June 30, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
April 25, 2022
Record last verified: 2022-04