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Completed

NCT Number: NCT04060797

Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease

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.

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Key information

Conditions

PAD

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

PTA

Device

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

Primary outcomes

  1. Change of Ankle Brachial Index (ABI) at 6-month Post-procedure.

    Time frame: From baseline to 6 months 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.

Secondary outcomes

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

    Time frame: From baseline to 3 months 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.

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

    Time frame: From baseline to 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.

  3. Change of Transcutaneous Oxygen Pressure (TcPO2)

    Time frame: From baseline to 6 months post procedure

    Use the Transcutaneous oxygen pressure (TcPO2) at 6-month post-procedure minus the baseline TcPO2.(the higher the value, the better the results)

  4. Change of Transcutaneous Oxygen Pressure (TcPO2)

    Time frame: From baseline to 3 months post procedure

    Use the Transcutaneous oxygen pressure (TcPO2) at 3-month post-procedure minus the baseline TcPO2.(the higher the value, the better the results)

  5. Change of Transcutaneous Oxygen Pressure (TcPO2)

    Time frame: From baseline to 1 week post procedure

    Use the Transcutaneous oxygen pressure (TcPO2) at 1 week post-procedure minus the baseline TcPO2.(the higher the value, the better the results)

  6. Rutherford Category

    Time frame: At 6 months post procedure

    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)

  7. Rutherford Category

    Time frame: At 3 months post procedure

    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)

  8. Rutherford Category

    Time frame: At 1 week post procedure

    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)

  9. NRS Score

    Time frame: At 6 months post procedure

    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)

  10. NRS Score

    Time frame: At 3 months post procedure

    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)

  11. NRS Score

    Time frame: At 1 week post procedure

    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)

  12. Number of Participants With MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)

    Time frame: From baseline to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2019
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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