Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease

Not Applicable

Recruiting

• Conditions: PAD

• Registration Number: NCT05345431
• Lead Sponsor: Zhongda Hospital

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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-20
• Last Update Submitted: 2022-04-20
• Study Start: 2022-04-25
• Study First Posted: 2022-04-25
• Last Update Posted: 2022-04-25
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ischemia relief	from baseline to 6 months after procedure	Changes of the ankle brachial index(ABI)

Secondary Outcome Measures

Name	Time	Method
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)
Ischemia relief	from baseline to 3 months after procedure	Changes of the ankle brachial index(ABI)
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)

Trial Locations

Locations (1)

Zhongda Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China