Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease

NCT04060797 | Completed Results

• 1 other identifier: ED-PAD
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

PAD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change of Ankle Brachial Index (ABI) at 3-month Post-procedure.

  From baseline to 3 months post procedure

• Change of Ankle Brachial Index (ABI) at 1-week Post-procedure.

  From baseline to 1 week post procedure

• Change of Transcutaneous Oxygen Pressure (TcPO2)

  From baseline to 6 months post procedure

• Change of Transcutaneous Oxygen Pressure (TcPO2)

  From baseline to 3 months post procedure

• Change of Transcutaneous Oxygen Pressure (TcPO2)

  From baseline to 1 week post procedure

Study Arms (2)

The control group

OTHER

Treating with balloon dilation or stent implantation only,

Device: PTA

The EDN group

EXPERIMENTAL

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: endovascular denervation; Device: PTA

Interventions

endovascular denervation DEVICE

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 DEVICE

Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)

The EDN group; The control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Results Point of Contact

• Title: Dr. Gaojun Teng
• Organization: Zhongda Hospital Affiliated to Southeast University

gjteng@vip.sina.com

13805175100

Study Officials

• Gao-Jun Teng, MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 19, 2019
• Study Start: August 23, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: May 20, 2024
• Results First Posted: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)