Actively Recruiting
Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
Led by Zhongda Hospital · Updated on 2022-04-25
54
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Peripheral arterial disease (PAD) causes poor blood flow to the lower limbs, leading to pain, lower skin temperature, and potentially ulcers or tissue death. This condition involves overactive sympathetic nerves, which contribute to the disease. Researchers are evaluating a multi-electrode radiofrequency ablation system to reduce this nerve activity and improve symptoms in people with PAD. The study compares two treatments: one group receives balloon dilation or stent implantation alone, while the other group receives endovascular denervation (EDN) using a radiofrequency catheter at a specific artery site before the balloon or stent procedure. This minimally invasive approach aims to restore normal nerve function and relieve limb ischemia. Participants will be monitored over 6 months to assess improvements in ischemia, pain relief, and clinical benefits. Researchers will measure relief from ischemia at 3 and 6 months after treatment. The study involves random assignment to treatment groups, with no masking, and includes various evaluations to track patient outcomes and safety throughout the study.
CONDITIONS
Brief Title
Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible subjects aged 18 to 75 years
- Clinically confirmed peripheral arterial disease patients in Rutherford category II to VI
You will not qualify if you...
- Thrombolytic therapy performed within 30 days
- Patients who had undergone vascular bypass surgery before this study
- Allergy or contraindication to antiplatelet drugs, anticoagulants, thrombolytic drugs, or contrast agents
- Patients with obvious bleeding tendency, coagulation dysfunction, hypercoagulability, or 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 less than 24 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo either endovascular denervation combined with balloon dilation or stent implantation, or balloon dilation or stent implantation alone.
1 procedure visit (in-person)
Duration - Up to 6 months
Participants are monitored for ischemia relief, clinical benefit, and pain relief after the procedure.
Visits at 3 and 6 months post-procedure (in-person)
Trial Site Locations
Total: 1 location
1
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
G
Gao-Jun Teng, MD
G
Guo-Feng Zhao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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