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Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease

NCT04060797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-05-20

Study results available
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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.

Conditions

  • PAD

Interventions

DEVICE

endovascular denervation

Treating with endovascular denervation (EDN) at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation

DEVICE

PTA

Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)

Sponsors & Collaborators

  • Zhongda Hospital

    lead OTHER

Principal Investigators

  • Gao-Jun Teng, MD · Zhongda Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-23
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04060797 on ClinicalTrials.gov