Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease

Southeast University

Status: Completed

Conditions: PAD

Treatments: Device: PTA; Device: endovascular denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT04060797

ED-PAD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

38 participants in 2 patient groups

The control group

Other group

Description:

Treating with balloon dilation or stent implantation only,

Treatment:

Device: PTA

The EDN group

Experimental group

Description:

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.

Treatment:

Device: endovascular denervation

Device: PTA