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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The control group | Other | Treating with balloon dilation or stent implantation only, |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gao-Jun Teng, MD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, Southeast University | Nanjing | Jiangsu | 210009 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | The Control Group | Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA) |
| FG001 | The EDN Group | 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. 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | The Control Group | Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA) |
| BG001 | The EDN Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Standard Deviation | ratio | From baseline to 6 months post procedure |
|
From baseline to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Control Group | Treating with balloon dilation or stent implantation only, PTA: Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hematoma at puncture site | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gaojun Teng | Zhongda Hospital Affiliated to Southeast University | 13805175100 | gjteng@vip.sina.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2018 | May 13, 2024 | Prot_SAP_000.pdf |
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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
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| PTA | Device | Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA) |
|
| From baseline to 3 months post procedure |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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.
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)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Median | Standard Deviation | Kg |
|
| OG001 |
| The EDN Group |
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. 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) |
|
|
| 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. | Posted | Median | Standard Deviation | ratio | 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. | Posted | Median | Standard Deviation | ratio | 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) | Posted | Median | Standard Deviation | mmHg | 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) | Posted | Median | Standard Deviation | mmHg | 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) | Posted | Median | Standard Deviation | mmHg | 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) | Posted | Count of Participants | Participants | At 6 months post procedure |
|
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|
| 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) | Posted | Count of Participants | Participants | At 3 months post procedure |
|
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| 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) | Posted | Count of Participants | Participants | At 1 week post procedure |
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| 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) | Posted | Median | Inter-Quartile Range | score on a scale | At 6 months post procedure |
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| 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) | Posted | Median | Inter-Quartile Range | score on a scale | At 3 months post procedure |
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| 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) | Posted | Median | Inter-Quartile Range | score on a scale | At 1 week post procedure |
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| 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. | Posted | Number | participants | From baseline to 6 months |
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| 0 |
| 19 |
| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | The EDN Group | 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. 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) | 0 | 19 | 0 | 19 | 2 | 19 |
| local arterial vasospasm | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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