Clinical trial NCT04060797: Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease
Official title: Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease (ED-PAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PAD
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly divided into two groups: the endovascular revascularization (ER) group and the ER + endovascular denervation (EDN) group treating with EDN at the site of the distal iliac artery or the proximal superficial femoral artery before ER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Ankle Brachial Index (ABI) at 6-month Post-procedure.
timeFrame: From baseline to 6 months post procedure
Secondary outcomes:
measure: Change of Ankle Brachial Index (ABI) at 3-month Post-procedure.
timeFrame: From baseline to 3 months post procedure
measure: Change of Ankle Brachial Index (ABI) at 1-week Post-procedure.
timeFrame: From baseline to 1 week post procedure
measure: Change of Transcutaneous Oxygen Pressure (TcPO2)
timeFrame: From baseline to 6 months post procedure
measure: Change of Transcutaneous Oxygen Pressure (TcPO2)
timeFrame: From baseline to 3 months post procedure
measure: Change of Transcutaneous Oxygen Pressure (TcPO2)
timeFrame: From baseline to 1 week post procedure
measure: Rutherford Category
timeFrame: At 6 months post procedure
measure: Rutherford Category
timeFrame: At 3 months post procedure
measure: Rutherford Category
timeFrame: At 1 week post procedure
measure: NRS Score
timeFrame: At 6 months post procedure
measure: NRS Score
timeFrame: At 3 months post procedure
measure: NRS Score
timeFrame: At 1 week post procedure
measure: Number of Participants With MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-Jun Teng, MD
role: PRINCIPAL_INVESTIGATOR
References: