Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease

Not Applicable

Completed

Conditions: PAD

Interventions: Device: PTA
Device: endovascular denervation

Registration Number: NCT04060797

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

Inclusion Criteria

eligible subjects aged 18-75 years,
clinically confirmed PAD in the lower extremities,
Rutherford category II-VI.

Exclusion Criteria

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,
serious liver and kidney diseases,
history of hemorrhagic stroke within last month or ischemic stroke or transient ischemic attack within 2 weeks,
pacemaker implants,
patients who are pregnant, breast-feeding or planning pregnancy,
expected survival < 24 months.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The control group	PTA	Treating with balloon dilation or stent implantation only,
The EDN group	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.
The EDN group	PTA	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.

Primary Outcome Measures

Name	Time	Method
Change of Ankle Brachial Index (ABI) at 6-month Post-procedure.	From baseline to 6 months post procedure	The change value was using the ankle brachial index (ABI) at 6-month post-procedure minus the baseline ABI in two group. (the group which have higher change value mean the better result). "Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease.

Secondary Outcome Measures

Name	Time	Method
NRS Score	At 1 week post procedure	Median of numeric rating scale (NRS) scores in 1 week (NRS scores includes a total of 0-10 grades, No pain (0), Mild pain (1 \~ 3), Moderate pain (4 \~ 6), Severe pain (7 \~ 10), the lower the grade, the better the results)
Change of Transcutaneous Oxygen Pressure (TcPO2)	From baseline to 1 week post procedure	Use the Transcutaneous oxygen pressure (TcPO2) at 1 week post-procedure minus the baseline TcPO2.(the higher the value, the better the results)
Change of Ankle Brachial Index (ABI) at 1-week Post-procedure.	From baseline to 1 week post procedure	The change value was using the ankle brachial index (ABI) at 1-week post-procedure minus the baseline ABI in two group. (the group which have higher change value mean the better result) "Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease.
Change of Ankle Brachial Index (ABI) at 3-month Post-procedure.	From baseline to 3 months post procedure	The change value was using the ankle brachial index (ABI) at 3-month post-procedure minus the baseline ABI in two group. (the group which have higher change value mean the better result) "Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease.
Rutherford Category	At 1 week post procedure	Number of Subjects with a decrease in Rutherford Category in 1 week (Rutherford category includes a total of 0-6 grades, grade 0 was asymptomatic, grade 1 was mild intermittent claudication, grade 2 was moderate intermittent claudication, grade 3 was severe intermittent claudication, grade 4 was resting pain, grade 5 was minor tissue defect, grade 6 was tissue ulcer, gangrene. The lower the grade, the better the results)
Number of Participants With MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)	From baseline to 6 months	MACE (Major adverse cardiovascular events, defined as cerebrovascular accident, myocardial infarction, or death.) and MALE (Major adverse limb events, defined as untreated loss of patency of the revascularization, reintervention on the revascularized segment, or major amputation of the revascularized limb) occurred cases from baseline to 6 months.