PAD
Conditions
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.
Interventions
DEVICEendovascular denervation
Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation
DEVICEPTA
Treating with balloon dilation or stent implantation
Sponsors
Zhongda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ischemia relief | from baseline to 6 months after procedure | Changes of the ankle brachial index(ABI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ischemia relief | from baseline to 3 months after procedure | Changes of the ankle brachial index(ABI) |
| clinical benefit | from baseline to 3, 6 months after procedure | Changes of the Rutherford category(Rutherford category includes a total of 0-6 grades, the lower the grade, the better the results) |
| pain relief | from baseline to 3 ,6 months after procedure | 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) |
Countries
China
Contacts
Primary ContactGao-Jun Teng, MD
Backup ContactGuo-Feng Zhao, MD
Outcome results
None listed