Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
ConditionPAD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhongda Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
eligible subjects aged 18-75 years,
clinically confirmed PAD patients in Rutherford category II-VI.
Disqualifiers
thrombolytic therapy performed within 30 days,
patients who had undergone vascular bypass surgery before this study,
allergy or contraindication of antiplatelet drugs, anticoagulants, thrombolytic drugs and contrast agents,
patients with obvious bleeding tendency, coagulation dysfunction, hypercoagulability and blood system diseases,
Trial design
Design model
Parallel
Treatments tested in this trial
endovascular denervation
DeviceTreating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation
PTA
DeviceTreating with balloon dilation or stent implantation
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: The control groupOther 1 intervention
Group B: The EDN groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Ischemia relief
Changes of the ankle brachial index(ABI)
Time frame
from baseline to 6 months after procedureSecondary outcomes
1
Ischemia relief
Changes of the ankle brachial index(ABI)
Time frame
from baseline to 3 months after procedure2
clinical benefit
Changes of the Rutherford category(Rutherford category includes a total of 0-6 grades, the lower the grade, the better the results)
Time frame
from baseline to 3, 6 months after procedure3
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)
Time frame
from baseline to 3 ,6 months after procedureSponsors and contacts
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Source ClinicalTrials.gov