Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease

PAD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04060797
• Other study ID #: ED-PAD
• Status: Completed
• Phase: N/A
• Start date: August 23, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2024
• Source: Zhongda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• PAD
• Peripheral Arterial Disease

Intervention

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

Locations

Country	Name	City	State
China	Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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