Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease

PAD Clinical Trial

— EDPAD  

Official title:

Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345431
• Other study ID #: EDN-PAD
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2022
• Source: Zhongda Hospital
• Contact: Gao-Jun Teng, MD
• Phone: +86 25 83272121
• Email: gjteng[@]seu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• PAD
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• endovascular denervation
Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation
• PTA
Treating with balloon dilation or stent implantation

Locations

Country	Name	City	State
China	Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemia relief	Changes of the ankle brachial index(ABI)	from baseline to 6 months after procedure
Secondary	Ischemia relief	Changes of the ankle brachial index(ABI)	from baseline to 3 months after procedure
Secondary	clinical benefit	Changes of the Rutherford category(Rutherford category includes a total of 0-6 grades, the lower the grade, the better the results)	from baseline to 3, 6 months after procedure
Secondary	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)	from baseline to 3 ,6 months after procedure