PAD
Conditions
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.
Detailed 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.
Interventions
DEVICEPTA
Treating with balloon dilation or stent implantation which were Percutaneous transluminal angioplasty (PTA)
DEVICEendovascular 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
Sponsors
Zhongda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Ankle Brachial Index (ABI) at 6-month Post-procedure. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change of Ankle Brachial Index (ABI) at 1-week Post-procedure. | 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. |
| Change of Transcutaneous Oxygen Pressure (TcPO2) | 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) |
| Change of Ankle Brachial Index (ABI) at 3-month Post-procedure. | 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. |
| NRS Score | 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) |
| Number of Participants With MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events) | 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. |
| Rutherford Category | 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) |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 19 |
| 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) | 19 |
| Total | 38 |
Baseline characteristics
| Characteristic | The Control Group | The EDN Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 15 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 4 Participants | 11 Participants |
| Age, Continuous | 67.53 years STANDARD_DEVIATION 5.55 | 68.95 years STANDARD_DEVIATION 6.76 | 68.24 years STANDARD_DEVIATION 6.14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 19 Participants | 38 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 33 Participants |
| Weight | 67.95 Kg STANDARD_DEVIATION 9.59 | 68.37 Kg STANDARD_DEVIATION 5.34 | 68.15 Kg STANDARD_DEVIATION 7.76 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 1 / 19 | 2 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
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.
Time frame: From baseline to 6 months post procedure
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| The Control Group | Change of Ankle Brachial Index (ABI) at 6-month Post-procedure. | 0.24 ratio | Standard Deviation 0.15 |
| The EDN Group | Change of Ankle Brachial Index (ABI) at 6-month Post-procedure. | 0.44 ratio | Standard Deviation 0.3 |
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.
Time frame: From baseline to 1 week post procedure
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| The Control Group | Change of Ankle Brachial Index (ABI) at 1-week Post-procedure. | 0.21 ratio | Standard Deviation 0.2 |
| The EDN Group | Change of Ankle Brachial Index (ABI) at 1-week Post-procedure. | 0.28 ratio | Standard Deviation 0.33 |
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.
Time frame: From baseline to 3 months post procedure
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| The Control Group | Change of Ankle Brachial Index (ABI) at 3-month Post-procedure. | 0.28 ratio | Standard Deviation 0.19 |
| The EDN Group | Change of Ankle Brachial Index (ABI) at 3-month Post-procedure. | 0.48 ratio | Standard Deviation 0.31 |
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)
Time frame: From baseline to 6 months post procedure
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| The Control Group | Change of Transcutaneous Oxygen Pressure (TcPO2) | 4.95 mmHg | Standard Deviation 13.43 |
| The EDN Group | Change of Transcutaneous Oxygen Pressure (TcPO2) | 15.68 mmHg | Standard Deviation 16.72 |
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)
Time frame: From baseline to 3 months post procedure
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| The Control Group | Change of Transcutaneous Oxygen Pressure (TcPO2) | 5.58 mmHg | Standard Deviation 15.67 |
| The EDN Group | Change of Transcutaneous Oxygen Pressure (TcPO2) | 15.68 mmHg | Standard Deviation 15.82 |
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)
Time frame: From baseline to 1 week post procedure
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| The Control Group | Change of Transcutaneous Oxygen Pressure (TcPO2) | 5.16 mmHg | Standard Deviation 16.93 |
| The EDN Group | Change of Transcutaneous Oxygen Pressure (TcPO2) | 7.12 mmHg | Standard Deviation 15.9 |
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)
Time frame: At 3 months post procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| The Control Group | NRS Score | 0 score on a scale |
| The EDN Group | NRS Score | 0 score on a scale |
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)
Time frame: At 1 week post procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| The Control Group | NRS Score | 1 score on a scale |
| The EDN Group | NRS Score | 0 score on a scale |
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)
Time frame: At 6 months post procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| The Control Group | NRS Score | 0 score on a scale |
| The EDN Group | NRS Score | 0 score on a scale |
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.
Time frame: From baseline to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| The Control Group | Number of Participants With MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events) | 0 participants |
| The EDN Group | Number of Participants With MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events) | 0 participants |
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)
Time frame: At 1 week post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Control Group | Rutherford Category | 8 Participants |
| The EDN Group | Rutherford Category | 11 Participants |
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)
Time frame: At 3 months post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Control Group | Rutherford Category | 13 Participants |
| The EDN Group | Rutherford Category | 19 Participants |
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)
Time frame: At 6 months post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Control Group | Rutherford Category | 17 Participants |
| The EDN Group | Rutherford Category | 19 Participants |