Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease

Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease (ED-PAD)

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.

Study Overview

• Status: Completed
• Conditions: PAD
• Intervention / Treatment: Device: PTA; Device: endovascular denervation

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital, Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. eligible subjects aged 18-75 years,
2. clinically confirmed PAD in the lower extremities,
3. 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 last 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: The control group; Treating with balloon dilation or stent implantation only,	Device: PTA; Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
Experimental: The EDN group; 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Ankle Brachial Index (ABI) at 6-month 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.	From baseline to 6 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Ankle Brachial Index (ABI) at 3-month 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.	From baseline to 3 months post procedure
Change of Ankle Brachial Index (ABI) at 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.	From baseline to 1 week post procedure
Change of Transcutaneous Oxygen Pressure (TcPO2)	Use the Transcutaneous oxygen pressure (TcPO2) at 6-month post-procedure minus the baseline TcPO2.(the higher the value, the better the results)	From baseline to 6 months post procedure
Change of Transcutaneous Oxygen Pressure (TcPO2)	Use the Transcutaneous oxygen pressure (TcPO2) at 3-month post-procedure minus the baseline TcPO2.(the higher the value, the better the results)	From baseline to 3 months post procedure
Change of Transcutaneous Oxygen Pressure (TcPO2)	Use the Transcutaneous oxygen pressure (TcPO2) at 1 week post-procedure minus the baseline TcPO2.(the higher the value, the better the results)	From baseline to 1 week post procedure
Rutherford Category	Number of Subjects with a decrease in Rutherford Category in 6 months (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)	At 6 months post procedure
Rutherford Category	Number of Subjects with a decrease in Rutherford Category in 3 months (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)	At 3 months post procedure
Rutherford Category	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)	At 1 week post procedure
NRS Score	Median of numeric rating scale (NRS) scores in 6 months (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)	At 6 months post procedure
NRS Score	Median of numeric rating scale (NRS) scores in 3 months (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)	At 3 months post procedure
NRS Score	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)	At 1 week post procedure
Number of Participants With MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)	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.	From baseline to 6 months

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Principal Investigator: Gao-Jun Teng, MD, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease
• Other Study ID Numbers: ED-PAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No