Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05345431

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

218 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 75 years
  • Clinically confirmed peripheral arterial disease (PAD) patients classified in Rutherford categories II to VI
Not Eligible

You will not qualify if you...

  • Received thrombolytic therapy within the last 30 days
  • Previous vascular bypass surgery
  • Allergy or contraindication to antiplatelet drugs, anticoagulants, thrombolytic drugs, or contrast agents
  • Bleeding disorders, coagulation dysfunction, hypercoagulability, or blood system diseases
  • Serious liver or kidney diseases
  • History of hemorrhagic stroke within the past month or ischemic stroke/transient ischemic attack within the past two weeks
  • Having a pacemaker implant
  • Pregnant, breastfeeding, or planning pregnancy
  • Expected survival less than 24 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Actively Recruiting

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Research Team

G

Gao-Jun Teng, MD

CONTACT

G

Guo-Feng Zhao, MD

CONTACT

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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